Regulations last checked for updates: Nov 22, 2024
Title 42 - Public Health last revised: Nov 19, 2024
§ 484.300 - Basis and scope of subpart.
This subpart is established under sections 1102, 1115A, and 1871 of the Act (42 U.S.C. 1315a), which authorizes the Secretary to issue regulations to operate the Medicare program and test innovative payment and service delivery models to improve coordination, quality, and efficiency of health care services furnished under Title XVIII.
§ 484.305 - Definitions.
As used in this subpart—
Applicable measure means a measure for which a competing HHA has provided a minimum of—
(1) Twenty home health episodes of care per year for the OASIS-based measures;
(2) Twenty home health episodes of care per year for the claims-based measures; or
(3) Forty completed surveys for the HHCAHPS measures.
Applicable percent means a maximum upward or downward adjustment for a given performance year, not to exceed the following:
(1) For CY 2018, 3-percent.
(2) For CY 2019, 5-percent.
(3) For CY 2020, 6-percent.
(4) For CY 2021, 7-percent.
Benchmark refers to the mean of the top decile of Medicare-certified HHA performance on the specified quality measure during the baseline period, calculated for each state.
Competing home health agency or agencies means an agency or agencies:
(1) That has or have a current Medicare certification; and,
(2) Is or are being paid by CMS for home health care delivered within any of the states specified in § 484.310.
Home health prospective payment system (HH PPS) refers to the basis of payment for home health agencies as set forth in §§ 484.200 through 484.245.
Larger-volume cohort means the group of competing home health agencies within the boundaries of selected states that are participating in HHCAHPs in accordance with § 484.250.
Linear exchange function is the means to translate a competing HHA's Total Performance Score into a value-based payment adjustment percentage.
New measures means those measures to be reported by competing HHAs under the HHVBP Model that are not otherwise reported by Medicare-certified HHAs to CMS and were identified to fill gaps to cover National Quality Strategy Domains not completely covered by existing measures in the home health setting.
Payment adjustment means the amount by which a competing HHA's final claim payment amount under the HH PPS is changed in accordance with the methodology described in § 484.325.
Performance period means the time period during which data are collected for the purpose of calculating a competing HHA's performance on measures.
Selected state(s) means those nine states that were randomly selected to compete/participate in the HHVBP Model via a computer algorithm designed for random selection and identified at § 484.310(b).
Smaller-volume cohort means the group of competing home health agencies within the boundaries of selected states that are exempt from participation in HHCAHPs in accordance with § 484.250.
Total Performance Score means the numeric score ranging from 0 to 100 awarded to each competing HHA based on its performance under the HHVBP Model.
Value-based purchasing means measuring, reporting, and rewarding excellence in health care delivery that takes into consideration quality, efficiency, and alignment of incentives. Effective health care services and high performing health care providers may be rewarded with improved reputations through public reporting, enhanced payments through differential reimbursements, and increased market share through purchaser, payer, and/or consumer selection.
[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 82 FR 51752, Nov. 7, 2017; 86 FR 62422, Nov. 9, 2021]
§ 484.310 - Applicability of the Home Health Value-Based Purchasing (HHVBP) Model.
(a) General rule. The HHVBP Model applies to all Medicare-certified home health agencies (HHAs) in selected states.
(b) Selected states. Nine states have been selected in accordance with CMS's selection methodology. All Medicare-certified HHAs that provide services in Massachusetts, Maryland, North Carolina, Florida, Washington, Arizona, Iowa, Nebraska, and Tennessee will be required to compete in this model.
§ 484.315 - Data reporting for measures and evaluation and the public reporting of model data under the Home Health Value-Based Purchasing (HHVBP) Model.
(a) Competing home health agencies will be evaluated using a set of quality measures.
(b) Competing home health agencies in selected states will be required to report information on New Measures, as determined appropriate by the Secretary, to CMS in the form, manner, and at a time specified by the Secretary, and subject to any exceptions or extensions CMS may grant to home health agencies for the Public Health Emergency as defined in § 400.200 of this chapter.
(c) Competing home health agencies in selected states will be required to collect and report such information as the Secretary determines is necessary for purposes of monitoring and evaluating the HHVBP Model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a).
[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 84 FR 60646, Nov. 8, 2019; 85 FR 27628, May 8, 2020; 86 FR 62422, Nov. 9, 2021]
§ 484.320 - Calculation of the Total Performance Score.
A competing home health agency's Total Performance Score for a model year is calculated as follows:
(a) CMS will award points to the competing home health agency for performance on each of the applicable measures excluding the New Measures.
(b) CMS will award points to the competing home health agency for reporting on each of the New Measures worth up to ten percent of the Total Performance Score.
(c)(1) For performance years 1 through 3, CMS will sum all points awarded for each applicable measure excluding the New Measures, weighted equally at the individual measure level to calculate a value worth 90 percent of the Total Performance Score.
(2) For performance years 4 and 5, CMS will sum all points awarded for each applicable measure within each category of measures (OASIS-based, claims-based and HHCAHPS) excluding the New Measures, weighted at 35 percent for the OASIS-based measure category, 35 percent for the claims-based measure category, and 30 percent for the HHCAHPS measure category when all three measure categories are reported, to calculate a value worth 90 percent of the Total Performance Score.
(d) The sum of the points awarded to a competing HHA for each applicable measure and the points awarded to a competing HHA for reporting data on each New Measure is the competing HHA's Total Performance Score for the calendar year.
[80 FR 68718, Nov. 5, 2015, as amended at 81 FR 76796, Nov. 3, 2016; 83 FR 56630, Nov. 13, 2018]
§ 484.325 - Payments for home health services under Home Health Value-Based Purchasing (HHVBP) Model.
CMS will determine a payment adjustment up to the maximum applicable percentage, upward or downward, under the HHVBP Model for each competing home health agency based on the agency's Total Performance Score using a linear exchange function. Payment adjustments made under the HHVBP Model will be calculated as a percentage of otherwise-applicable payments for home health services provided under section 1895 of the Act (42 U.S.C. 1395fff).
§ 484.330 - Process for determining and applying the value-based payment adjustment under the Home Health Value-Based Purchasing (HHVBP) Model.
(a) General. Competing home health agencies will be ranked within the larger-volume and smaller-volume cohorts in selected states based on the performance standards that apply to the HHVBP Model for the baseline year, and CMS will make value-based payment adjustments to the competing HHAs as specified in this section.
(b) Calculation of the value-based payment adjustment amount. The value-based payment adjustment amount is calculated by multiplying the Home Health Prospective Payment final claim payment amount as calculated in accordance with § 484.205 by the payment adjustment percentage.
(c) Calculation of the payment adjustment percentage. The payment adjustment percentage is calculated as the product of: The applicable percent as defined in § 484.320, the competing HHA's Total Performance Score divided by 100, and the linear exchange function slope.
§ 484.335 - Appeals process for the Home Health Value-Based Purchasing (HHVBP) Model.
(a) Requests for recalculation—(1) Matters for recalculation. Subject to the limitations on review under section 1115A of the Act, a HHA may submit a request for recalculation under this section if it wishes to dispute the calculation of the following:
(i) Interim performance scores.
(ii) Annual total performance scores.
(iii) Application of the formula to calculate annual payment adjustment percentages.
(2) Time for filing a request for recalculation. A recalculation request must be submitted in writing within 15 calendar days after CMS posts the HHA-specific information on the HHVBP Secure Portal, in a time and manner specified by CMS.
(3) Content of request. (i) The provider's name, address associated with the services delivered, and CMS Certification Number (CCN).
(ii) The basis for requesting recalculation to include the specific quality measure data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect.
(iii) Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box).
(iv) The HHA may include in the request for recalculation additional documentary evidence that CMS should consider. Such documents may not include data that was to have been filed by the applicable data submission deadline, but may include evidence of timely submission.
(4) Scope of review for recalculation. In conducting the recalculation, CMS will review the applicable measures and performance scores, the evidence and findings upon which the determination was based, and any additional documentary evidence submitted by the home health agency. CMS may also review any other evidence it believes to be relevant to the recalculation.
(5) Recalculation decision. CMS will issue a written notification of findings. A recalculation decision is subject to the request for reconsideration process in accordance with paragraph (b) of this section.
(b) Requests for reconsideration—(1) Matters for reconsideration. A home health agency may request reconsideration of the recalculation of its annual total performance score and payment adjustment percentage following a decision on the home health agency's recalculation request submitted under paragraph (a) of this section, or the decision to deny the recalculation request submitted under paragraph (a) of this section.
(2) Time for filing a request for reconsideration. The request for reconsideration must be submitted via the HHVBP Secure Portal within 15 calendar days from CMS' notification to the HHA contact of the outcome of the recalculation process.
(3) Content of request. (i) The name of the HHA, address associated with the services delivered, and CMS Certification Number (CCN).
(ii) The basis for requesting reconsideration to include the specific quality measure data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect.
(iii) Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box).
(iv) The HHA may include in the request for reconsideration additional documentary evidence that CMS should consider. Such documents may not include data that was to have been filed by the applicable data submission deadline, but may include evidence of timely submission.
(4) Scope of review for reconsideration. In conducting the reconsideration review, CMS will review the applicable measures and performance scores, the evidence and findings upon which the determination was based, and any additional documentary evidence submitted by the HHA. CMS may also review any other evidence it believes to be relevant to the reconsideration. The HHA must prove its case by a preponderance of the evidence with respect to issues of fact.
(5) Reconsideration decision. CMS reconsideration officials will issue a written determination.
[81 FR 76796, Nov. 3, 2016]
§ 484.340 - Basis and scope of this subpart.
This subpart is established under sections 1102, 1115A, and 1871 of the Act (42 U.S.C. 1315a), which authorizes the Secretary to issue regulations to operate the Medicare program and test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care furnished to individuals under Titles XVIII and XIX of the Act.
§ 484.345 - Definitions.
As used in this subpart—
Achievement threshold means the median (50th percentile) of home health agency performance on a measure during a Model baseline year, calculated separately for the larger- and smaller-volume cohorts.
Applicable measure means a measure (OASIS- and claims-based measures) or a measure component (HHCAHPS survey measure) for which a competing HHA has provided a minimum of one of the following:
(1) Twenty home health episodes of care per year for each of the OASIS-based measures.
(2) Twenty home health episodes of care per year for each of the claims-based measures.
(3) Forty completed surveys for each component included in the HHCAHPS survey measure.
Applicable percent means a maximum upward or downward adjustment for a given payment year based on the applicable performance year, not to exceed 5 percent.
Benchmark refers to the mean of the top decile of Medicare-certified HHA performance on the specified quality measure during the Model baseline year, calculated separately for the larger- and smaller-volume cohorts.
Competing home health agency or agencies (HHA or HHAs) means an agency or agencies that meet the following:
(1) Has or have a current Medicare certification; and
(2) Is or are being paid by CMS for home health care services.
HHA baseline year means the calendar year used to determine the improvement threshold for each measure for each individual competing HHA.
Home health prospective payment system (HH PPS) refers to the basis of payment for HHAs as set forth in §§ 484.200 through 484.245.
Improvement threshold means an individual competing HHA's performance level on a measure during the HHA baseline year.
Larger-volume cohort means the group of competing HHAs that are participating in the HHCAHPS survey in accordance with § 484.245.
Linear exchange function is the means to translate a competing HHA's Total Performance Score into a value-based payment adjustment percentage.
Model baseline year means the calendar year used to determine the benchmark and achievement threshold for each measure for all competing HHAs.
Nationwide means the 50 States and the U.S. territories, including the District of Columbia.
Payment adjustment means the amount by which a competing HHA's final claim payment amount under the HH PPS is changed in accordance with the methodology described in § 484.370.
Payment year means the calendar year in which the applicable percent, a maximum upward or downward adjustment, applies.
Performance year means the calendar year during which data are collected for the purpose of calculating a competing HHA's performance on measures.
Pre-Implementation year means CY 2022.
Smaller-volume cohort means the group of competing HHAs that are exempt from participation in the HHCAHPS survey in accordance with § 484.245.
Total Performance Score (TPS) means the numeric score ranging from 0 to 100 awarded to each competing HHA based on its performance under the expanded HHVBP Model.
[86 FR 62422, Nov. 9, 2021, as amended at 87 FR 66887, Nov. 4, 2022]
§ 484.350 - Applicability of the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
(a) General rule. The expanded HHVBP Model applies to all Medicare-certified HHAs nationwide.
(b) New HHAs. A new HHA is certified by Medicare on or after January 1, 2022. For new HHAs, the following apply:
(1) The HHA baseline year is the first full calendar year of services beginning after the date of Medicare certification.
(2) The first performance year is the first full calendar year following the HHA baseline year.
(c) Existing HHAs. An existing HHA is certified by Medicare before January 1, 2022 and the HHA baseline year is CY 2022.
[86 FR 62422, Nov. 9, 2021, as amended at 87 FR 66887, Nov. 4, 2022]
§ 484.355 - Data reporting for measures and evaluation and the public reporting of model data under the expanded Home Health Value-Based Purchasing (HHVBP) Model.
(a) Competing home health agencies will be evaluated using a set of quality measures.
(1) Data submission. Except as provided in paragraph (d) of this section, for the pre-implementation year and each performance year, an HHA must submit all of the following to CMS in the form and manner, and at a time, specified by CMS:
(i) Data on measures specified under the expanded HHVBP model.
(ii) HHCAHPS survey data. For purposes of HHCAHPS Survey data submission, the following additional requirements apply:
(A) Survey requirements. An HHA must contract with an approved, independent HHCAHPS survey vendor to administer the HHCAHPS survey on its behalf.
(B) CMS approval. CMS approves an HHCAHPS survey vendor if the applicant has been in business for a minimum of 3 years and has conducted surveys of individuals and samples for at least 2 years.
(C) Definition of survey of individuals. For the HHCAHPS survey, a “survey of individuals” is defined as the collection of data from at least 600 individuals selected by statistical sampling methods and the data collected are used for statistical purposes.
(D) Administration of the HHCAHPS survey. No organization, firm, or business that owns, operates, or provides staffing for an HHA is permitted to administer its own HHCAHPS survey or administer the survey on behalf of any other HHA in the capacity as an HHCAHPS survey vendor. Such organizations are not approved by CMS as HHCAHPS survey vendors.
(E) Compliance by HHCAHPS survey vendors. Approved HHCAHPS survey vendors must fully comply with all HHCAHPS survey oversight activities, including allowing CMS and its HHCAHPS survey team to perform site visits at the vendors' company locations.
(F) Patient count exemption. An HHA that has less than 60 eligible unique HHCAHPS survey patients must annually submit to CMS its total HHCAHPS survey patient count to be exempt from the HHCAHPS survey reporting requirements for a calendar year.
(2) [Reserved]
(b) Competing home health agencies are required to collect and report such information as the Secretary determines is necessary for purposes of monitoring and evaluating the expanded HHVBP Model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a).
(c) For each performance year of the expanded HHVBP Model, CMS publicly reports applicable measure benchmarks and achievement thresholds for each cohort as well as all of the following for each competing HHA that qualified for a payment adjustment for the applicable performance year on a CMS website:
(1) The Total Performance Score.
(2) The percentile ranking of the Total Performance Score.
(3) The payment adjustment percentage.
(4) Applicable measure results and improvement thresholds.
(d) CMS may grant an exception with respect to quality data reporting requirements in the event of extraordinary circumstances beyond the control of the HHA. CMS may grant an exception as follows:
(1) A competing HHA that wishes to request an exception with respect to quality data reporting requirements must submit its request to CMS within 90 days of the date that the extraordinary circumstances occurred. Specific requirements for submission of a request for an exception are available on the CMS website.
(2) CMS may grant an exception to one or more HHAs that have not requested an exception if CMS determines either of the following:
(i) That a systemic problem with CMS data collection systems directly affected the ability of the HHA to submit data.
(ii) That an extraordinary circumstance has affected an entire region or locale.
§ 484.358 - HHVBP Measure removal factors.
CMS may remove a quality measure from the expanded HHVBP Model based on one or more of the following factors:
(a) Measure performance among HHAs is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made (that is, topped out).
(b) Performance or improvement on a measure does not result in better patient outcomes.
(c) A measure does not align with current clinical guidelines or practice.
(d) A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.
(e) A measure that is more proximal in time to desired patient outcomes for the particular topic is available.
(f) A measure that is more strongly associated with desired patient outcomes for the particular topic is available.
(g) Collection or public reporting of a measure leads to negative unintended consequences other than patient harm.
(h) The costs associated with a measure outweigh the benefit of its continued use in the program.
[88 FR 77878, Nov. 13, 2023]
§ 484.360 - Calculation of the Total Performance Score.
A competing HHA's Total Performance Score for a performance year is calculated as follows:
(a) CMS awards points to the competing home health agency for performance on each of the applicable measures.
(1) CMS awards greater than or equal to 0 points and less than 10 points for achievement to each competing home health agency whose performance on a measure during the applicable performance year meets or exceeds the applicable cohort's achievement threshold but is less than the applicable cohort's benchmark for that measure.
(2) CMS awards greater than 0 but less than 9 points for improvement to each competing home health agency whose performance on a measure during the applicable performance year exceeds the improvement threshold but is less than the applicable cohort's benchmark for that measure.
(3) CMS awards 10 points to a competing home health agency whose performance on a measure during the applicable performance year meets or exceeds the applicable cohort's benchmark for that measure.
(b) For all performance years, CMS calculates the weighted sum of points awarded for each applicable measure within each category of measures (OASIS-based, claims-based, and HHCAHPS Survey-based) weighted at 35 percent for the OASIS-based measure category, 35 percent for the claims-based measure category, and 30 percent for the HHCAHPS survey measure category when all three measure categories are reported, to calculate a value worth 100 percent of the Total Performance Score.
(1) Where a single measure category is not included in the calculation of the Total Performance Score for an individual HHA, due to insufficient volume for all of the measures in the category, the remaining measure categories are reweighted such that the proportional contribution of each remaining measure category is consistent with the weights assigned when all three measure categories are available. Where two measure categories are not included in the calculation of the Total Performance Score for an individual HHA, due to insufficient volume for all measures in those measure categories, the remaining measure category is weighted at 100 percent of the Total Performance Score.
(2) When one or more, but not all, of the measures in a measure category are not included in the calculation of the Total Performance Score for an individual HHA, due to insufficient volume for at least one measure in the category, the remaining measures in the category are reweighted such that the proportional contribution of each remaining measure is consistent with the weights assigned when all measures within the category are available.
(c) The sum of the weight-adjusted points awarded to a competing HHA for each applicable measure is the competing HHA's Total Performance Score for the calendar year. A competing HHA must have a minimum of five applicable measures to receive a Total Performance Score.
§ 484.365 - Payments for home health services under the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
CMS determines a payment adjustment up to the applicable percent, upward or downward, under the expanded HHVBP Model for each competing HHA based on the agency's Total Performance Score using a linear exchange function that includes all other HHAs in its cohort that received a Total Performance Score for the applicable performance year. Payment adjustments made under the expanded HHVBP Model are calculated as a percentage of otherwise-applicable payments for home health services provided under section 1895 of the Act (42 U.S.C. 1395fff).
§ 484.370 - Process for determining and applying the value-based payment adjustment under the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
(a) General. Competing home health agencies are ranked within the larger-volume and smaller-volume cohorts nationwide based on the performance standards in this part that apply to the expanded HHVBP Model, and CMS makes value-based payment adjustments to the competing HHAs as specified in this section.
(b) Calculation of the value-based payment adjustment amount. The value-based payment adjustment amount is calculated by multiplying the home health prospective payment final claim payment amount as calculated in accordance with § 484.205 by the payment adjustment percentage.
(c) Calculation of the payment adjustment percentage. The payment adjustment percentage is calculated as the product of all of the following:
(1) The applicable percent as defined in § 484.345.
(2) The competing HHA's Total Performance Score divided by 100.
(3) The linear exchange function slope.
[86 FR 62422, Nov. 9, 2021, as amended at 87 FR 66887, Nov. 4, 2022]
§ 484.375 - Appeals process for the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
(a) Requests for recalculation—(1) Matters for recalculation. Subject to the limitations on judicial and administrative review under section 1115A of the Act, a HHA may submit a request for recalculation under this section if it wishes to dispute the calculation of the following:
(i) Interim performance scores.
(ii) Annual total performance scores.
(iii) Application of the formula to calculate annual payment adjustment percentages.
(2) Time for filing a request for recalculation. A recalculation request must be submitted in writing within 15 calendar days after CMS posts the HHA-specific information on the CMS website, in a time and manner specified by CMS.
(3) Content of request. (i) The provider's name, address associated with the services delivered, and CMS Certification Number (CCN).
(ii) The basis for requesting recalculation to include the specific data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect.
(iii) Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box).
(iv) The HHA may include in the request for recalculation additional documentary evidence that CMS should consider. Such documents may not include data that was to have been filed by the applicable data submission deadline, but may include evidence of timely submission.
(4) Scope of review for recalculation. In conducting the recalculation, CMS reviews the applicable measures and performance scores, the evidence and findings upon which the determination was based, and any additional documentary evidence submitted by the HHA. CMS may also review any other evidence it believes to be relevant to the recalculation.
(5) Recalculation decision. CMS issues a written notification of findings. A recalculation decision is subject to the request for reconsideration process in accordance with paragraph (b) of this section.
(b) Requests for reconsideration—(1) Matters for reconsideration. A home health agency may request reconsideration of the recalculation of its annual total performance score and payment adjustment percentage following a decision on the HHA's recalculation request submitted under paragraph (a) of this section, or the decision to deny the recalculation request submitted under paragraph (a) of this section.
(2) Time for filing a request for reconsideration. The request for reconsideration must be submitted via the CMS website within 15 calendar days from CMS' notification to the HHA contact of the outcome of the recalculation process.
(3) Content of request. (i) The name of the HHA, address associated with the services delivered, and CMS Certification Number (CCN).
(ii) The basis for requesting reconsideration to include the specific data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect.
(iii) Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box).
(iv) The HHA may include in the request for reconsideration additional documentary evidence that CMS should consider. The documents may not include data that was to have been filed by the applicable data submission deadline, but may include evidence of timely submission.
(4) Scope of review for reconsideration. In conducting the reconsideration review, CMS reviews the applicable measures and performance scores, the evidence and findings upon which the determination was based, and any additional documentary evidence submitted by the HHA. CMS may also review any other evidence it believes to be relevant to the reconsideration. The HHA must prove its case by a preponderance of the evidence with respect to issues of fact.
(5) Reconsideration decision. (i) CMS reconsideration officials issue a written decision that is final and binding upon issuance unless the CMS Administrator—
(A) Renders a final determination reversing or modifying the reconsideration decision; or
(B) Does not review the reconsideration decision within 14 days of the request.
(ii) An HHA may request that the CMS Administrator review the reconsideration decision within 7 calendar days of the decision.
(iii) If the CMS Administrator receives a request to review, the CMS Administrator must do one of the following:
(A) Render a final determination based on his or her review of the reconsideration decision.
(B) Decline to review a reconsideration decision made by CMS.
(C) Choose to take no action.
(iv) If the CMS Administrator does not review an HHA's request within 14 days (as described in paragraph (b)(5)(iii)(B) or (C) of this section), the reconsideration official's written reconsideration decision is final.
[86 FR 62422, Nov. 9, 2021, as amended at 88 FR 77879, Nov. 13, 2023]
source: 54 FR 33367, Aug. 14, 1989, unless otherwise noted.
cite as: 42 CFR 484.375