CMS Proposed Updates to Policies and Payment Rates for End-Stage Renal Disease Facilities for CY 2016 and Proposed Changes to the ESRD Quality Incentive Program Proposed Payment System
On June 26, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that will update payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to beneficiaries on or after January 1, 2016. This rule also proposes new quality and performance measures to improve the quality of care by dialysis facilities treating patients with end-stage renal disease.
The ESRD proposed rule is one of several rules for calendar year 2016 that reflect a broader Administration-wide strategy to deliver better care at lower cost by finding better ways to deliver care, pay providers, and use information. Provisions in these rules are helping to move our health care system to one that values quality over quantity and focuses on reforms such as measuring for better health outcomes, focusing on disease prevention, helping patients live successfully at home, helping manage and improve chronic diseases, and fostering a more efficient and coordinated health care systems.
This proposed rule also includes changes to the ESRD Quality Incentive Program (QIP) for payment years (PYs) 2017-2019 under which payment incentives are applied to dialysis facilities to improve the quality of dialysis care. Under the ESRD QIP, facilities that do not achieve a minimum total performance score with respect to quality measures established in regulation receive a reduction in their payment rates under the ESRD PPS.
ESRD PPS BACKGROUND: Section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) amended the Social Security Act to require CMS to implement a bundled PPS for renal dialysis services furnished to Medicare beneficiaries for the treatment of ESRD effective January 1, 2011. The bundled payment under the ESRD PPS includes all renal dialysis services furnished for outpatient maintenance dialysis, including drugs and biologicals (with the exception of oral-only ESRD drugs until 2025) and other renal dialysis items and services that were formerly separately payable under the previous payment methodologies. The bundled payment rate is case-mix adjusted for a number of factors relating to patient characteristics. There are also additional adjustments for ESRD facilities that have a low patient volume and for home dialysis training. For high-cost patients, an ESRD facility may be eligible for outlier payments. Under the ESRD PPS for CY 2016, Medicare expects to pay approximately $9.0 billion to approximately 6,000 ESRD facilities for the costs associated with furnishing chronic maintenance dialysis services.
PAYMENT CHANGES TO THE ESRD PPS FOR CY 2016:
ESRD PPS Refinement: In accordance with section 632(c) of the American Taxpayers Relief Act of 2012 (ATRA), CMS analyzed the case mix payment adjustments under the ESRD PPS using more recent data. CMS is proposing to revise the adjustments by changing the adjustment payment amounts based on an updated regression analysis using CYs 2012 and 2013 ESRD claims and cost report data and proposing to remove two comorbidity payment adjustments (bacterial pneumonia and monoclonal gammopathy). Because the updated regression analysis conducted enabled CMS to analyze and revise the case-mix payment adjustments, CMS is also proposing revisions to the low-volume payment adjustment and proposing a new payment adjustment for rural ESRD facilities based on that regression analysis. Finally, CMS is proposing to revise the geographic proximity eligibility criterion for the low-volume payment adjustment and to remove grandfathering from the criteria for the adjustment.
Updated Payment Rates for the ESRD PPS: The proposed CY 2016 ESRD PPS base rate is $230.20. This amount reflects a reduced market basket increase as required by section 1881(b)(14)(F)(i)(I) of the Act, as amended by section 217(b)(2)(A)(ii) of the Protecting Access to Medicare Act of 2014 (PAMA) (0.15 percent), application of the wage index budget-neutrality adjustment factor (1.000332), and a refinement budget-neutrality adjustment factor (0.959703), so that total projected PPS payments in CY 2016 are equal to what the payments would have been in CY 2016 had the refinements not been implemented. The proposed CY 2016 ESRD PPS base rate is a reduction of $9.23 from the CY 2015 base rate of $239.43 ($239.43 x 1.0015 x 1.000332 x 0.959703 = $230.20).
Drug Designation Process: In accordance with section 217(c) of PAMA, CMS is proposing a drug designation process for: (1) determining when a product would no longer be considered an oral-only drug; and (2) including new injectable and intravenous products into the bundled payment under the ESRD PPS.
Annual Update to the Wage Index and Wage Index Floor: The ESRD wage indices are adjusted on an annual basis using the most current hospital wage data and the latest Core-Based Statistical Area (CBSA) delineations to account for differing wage levels in areas in which ESRD facilities are located. For CY 2016, CMS is not proposing any changes to the application of the wage index floor and we propose to continue to apply the current wage index floor (0.4000) to areas with wage index values below the floor.
Update to the Outlier Policy: Consistent with the proposal to annually update the outlier policy using the most current data, CMS is proposing to update the outlier services fixed dollar loss amounts for adult and pediatric patients and Medicare Allowable Payments (MAPs) for adult patients for CY 2016 using 2014 claims data. Based on the use of more current data, the fixed-dollar loss amount for pediatric beneficiaries would decrease from $54.35 to $49.99 and the MAP amount would decrease from $43.57 to $37.82, as compared to CY 2015 values. For adult beneficiaries, the fixed-dollar loss amount would decrease from $86.19 to $85.66 and the MAP amount would decrease from $51.29 to $48.15. In CY 2014, outlier payments were 0.9 percent of total ESRD PPS payment, that is, slightly less than the 1.0 percent target for outlier payments. Using CY 2014 claims data to update the outlier MAP and fixed dollar loss amounts for CY 2016 will increase outlier payments for ESRD beneficiaries requiring higher resource utilization.
Impact Analysis: CMS projects that the updates for CY 2016 will increase the total payments to all ESRD facilities by 0.3 percent compared with CY 2015. For hospital-based ESRD facilities, CMS projects an increase in total payments of 0.5 percent, while for freestanding facilities, the projected increase in total payments will be 0.2 percent
Low Volume Payment Adjustment (LVPA): ESRD facilities that consistently furnish a low volume of treatments (<4000 per year) receive a payment adjustment under the ESRD PPS. Eligibility for ESRD facilities that opened on January 1, 2011 and after are assessed by aggregating their treatments with other facilities that are within a 25 road mile radius and are under common ownership. In order to better target the LVPA to ESRD facilities to ensure access and encourage the efficient delivery of renal dialysis services, CMS is proposing to revise the LVPA eligibility criteria. The proposed criteria would exclude facilities of common ownership that are located within 5 miles from one another, regardless of when these facilities opened.
Payment for Oral-Only Drugs under the ESRD PPS: Payments for oral-only ESRD drugs are not included under the ESRD PPS until 2024 as required by section 632(b)(1) of ATRA, as amended by section 217(a) of PAMA. Section 204 of the Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014 (ABLE) provides that payment for oral-only ESRD drugs cannot be made under the ESRD PPS prior to January 1, 2025. Accordingly, CMS is proposing to delay payment for the inclusion of oral-only ESRD drugs until that date under the ESRD PPS.
End-Stage Renal Disease Quality Incentive Program
On June 26, 2015, the CMS issued a proposed rule that updates payment policies and rates and quality provisions under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to beneficiaries on or after January 1, 2016. This rule introduces new quality and performance measures to improve the quality of care by dialysis facilities treating patients with ESRD.
The ESRD PPS proposed rule is one of several rules for calendar year 2016 that reflect a broader Administration-wide strategy to create a health care system that results in better care, smarter spending, and healthier people. Provisions in these rules are helping to move our health care system to one that values quality over quantity and focuses on reforms such as measuring for better health outcomes, focusing on disease prevention, helping patients live successfully at home, helping manage and improve chronic diseases, and fostering a more efficient and coordinated health care systems.
The ESRD PPS proposed rule would also make changes to the ESRD QIP, for PYs 2017, 2018, and 2019, under which payment incentives are applied to dialysis facilities to improve the quality of dialysis care. Under the ESRD QIP, facilities that do not achieve a minimum total performance score established by regulation would receive a reduction in their payment rates under the ESRD PPS. Under the ESRD QIP, dialysis facilities are subject to a reduction of up to two percent from their Medicare payments each year based on their performance on certain quality measures.
CMS is proposing to add three new measures to the program for PY 2019, which includes the replacement of four existing measures of dialysis adequacy with a single, more broadly applicable dialysis adequacy measure, CMS is also proposing changes to certain administrative requirements and programmatic policies.
ESRD QIP BACKGROUND: Section 153(c) of the MIPPA amended the Social Security Act to require CMS to establish an ESRD QIP that selects measures, establishes performance standards, specifies a performance period for each PY, assesses the total performance of each facility, applies an appropriate payment reduction to each facility that does not meet a minimum total performance score, and publicly report the results. The ESRD QIP is intended to promote high-quality care by dialysis facilities treating patients with ESRD. This program changes the way CMS pays for the treatment of ESRD patients by linking a portion of payment directly to facility performance on quality measures. The ESRD QIP will reduce payments by up to two percent to ESRD facilities that do not meet or exceed a certain total performance score.
CHANGES TO THE ESRD QIP:
CHANGES TO THE PY 2017 ESRD QIP: The PY 2017 ESRD QIP measure set contains eight clinical measures and three reporting measures encompassing anemia management, dialysis adequacy, vascular access type, patient experience of care, infections, hospital readmissions, and mineral metabolism management. CMS is not proposing any new clinical or reporting measures for the PY 2017 ESRD QIP in the proposed rule, but is proposing to reinstate the qualifying patient attestations for the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems measure for PY 2017 and subsequent years, using the eligibility criteria finalized in the CY 2015 ESRD PPS final rule (79 FR 66170).
CHANGES TO THE PY 2018 ESRD QIP: The PY 2018 ESRD QIP measure set contains eleven clinical measures and five reporting measures encompassing anemia management, dialysis adequacy, vascular access type, patient experience of care, infections, mineral metabolism management, safety, pain management, depression management, and hospital readmissions. This represents an evolution of the program to encompass more quality-of-life issues. CMS is not proposing to adopt any new measures for PY 2018 in the CY 2016 ESRD PPS proposed rule, but is proposing one modification to the previously finalized measures. CMS determined that the calculation finalized for the Pain Assessment and Follow-Up reporting measure could unduly penalize facilities that do not encounter eligible patients in one of the two six-month periods evaluated under this measure. CMS is therefore proposing that, beginning with the PY 2018 ESRD QIP, if a facility treats no eligible patients in one of the two six-month periods, then that facility’s score will be based solely on the percentage of eligible patients treated in the other six-month period for whom the facility reports one of six conditions.
PROPOSALS FOR THE PY 2019 ESRD QIP: The PY 2019 ESRD QIP measure set contains eight clinical measures and seven reporting measures encompassing anemia management, dialysis adequacy, vascular access type, patient experience of care, infections, mineral metabolism management, safety, pain management, depression management, and hospital readmissions.
Clinical Measures: In an effort to ensure that the ESRD QIP maintains the most broadly applicable clinical measures and captures the quality of care provided to as many ESRD patients as possible, CMS is proposing to replace the four individual dialysis adequacy clinical measures—(1) Hemodialysis Adequacy: Minimum delivered hemodialysis dose; (2) Peritoneal Dialysis Adequacy: Delivered dose above minimum; (3) Pediatric Hemodialysis Adequacy: Minimum spKt/V; and (4) Pediatric Peritoneal Dialysis Adequacy—with a single, comprehensive clinical measure (the Dialysis Adequacy clinical measure) covering the patient populations previously captured by these four individual measures.
Reporting Measures: In addition to the five reporting measures previously finalized for use in the PY 2018 ESRD QIP, CMS is proposing to adopt two new reporting measures beginning in PY 2019—the Ultrafiltration Rate reporting measure and the Full-Season Influenza Vaccination reporting measure.
Additional ESRD QIP COMPONENTS: Beginning with the PY 2017 ESRD QIP, CMS is proposing to modify the “small-facility adjuster” calculation. Although the proposed new calculation methodology no longer relies upon a within-facility standard error, it preserves the intent of the adjuster to include as many facilities in the ESRD QIP as possible while ensuring that the measure scores are reliable. The rule also proposes to continue CMS’s data validation pilot program and a validation study of data used for the NHSN Bloodstream Infection in Hemodialysis Outpatients clinical measure. Lastly, beginning with the PY 2017 program year, CMS is proposing to use the current Hypercalcemia clinical measure as a measure specific to the conditions treated with oral-only drugs, in compliance with the Protecting Access to Medicare Act required by section 217(d) of to include.
The proposed rule will be issued in the June 26, 2015 Federal Register and can be downloaded from the Federal Register at: http://www.federalregister.gov/inspection.aspx.