Department of Health and Human Services
| Decision Date | 28 November 2018 |
| Docket Number | B-330523 |
| Parties | Department of Health and Human Services, Centers for Medicare and Medicaid Services: Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS |
| Court | Comptroller General of the United States |
The Honorable Orrin G. Hatch Chairman
The Honorable Ron Wyden Ranking Member
Committee on Finance United States Senate
The Honorable Greg Walden Chairman
The Honorable Frank Pallone, Jr. Ranking Member
Committee on Energy and Commerce House of Representatives
The Honorable Kevin Brady Chairman
The Honorable Richard Neal Ranking Member
Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) entitled "Medicare Program End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS" (RIN: 0938-AT28). We received the rule on November 7, 2018. It was published in the Federal Register as a final rule on November 14, 2018. 83 Fed Reg. 56, 922. The effective date of the final rule is January 1, 2019, except for amendments to 42 C.F.R. § 413.234 which are effective January 1, 2020.
The final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, it updates and rebases the ESRD market basket for CY 2019. This rule also updates requirements for the ESRD Quality Incentive Program (QIP), and makes technical amendments to correct existing regulations related to the Competitive Bidding Program (CBP) for certain Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS). Finally, this rule finalizes changes to bidding and pricing methodologies under the DMEPOS competitive bidding program; adjustments to DMEPOS fee schedule amounts using information from competitive bidding for items furnished from January 1, 2019, through December 31, 2020; new payment classes for oxygen and oxygen equipment and a new methodology for ensuring that new payment classes for oxygen and oxygen equipment are budget neutral; payment rules for multi-function ventilators or ventilators that perform functions of other durable medical equipment (DME); and revises the payment methodology for mail order items furnished in the Northern Mariana Islands. This rule also includes a summary of the feedback received for the request for information related to establishing fee schedule amounts for new DMEPOS items and services.
The Congressional Review Act (CRA) requires a 60-day delay in the effective date of a major rule from the date of publication in the Federal Register or receipt of the rule by Congress, whichever is later. 5 U.S.C. § 801(a)(3)(A). The rule was received by the House of Representatives on November 7, 2018, and received by the Senate on November 13, 2018. It was published in the Federal Register on November 14, 2018. 83 Fed. Reg. 56, 922. The rule has a stated effective date of January 1, 2019, except the amendments to 42 C.F.R. § 413.234, which are effective January 1, 2020. Therefore, except for the amendments effective January 1, 2020, the final rule does not have the required 60-day delay in its effective date.
Enclosed is our assessment of CMS's compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. If you have any questions about this report or wish to contact GAO officials responsible for the evaluation work relating to the subject matter of the rule, please contact Shirley A. Jones, Assistant General Counsel, at (202) 512-8156.
REPORT UNDER 5 U.S.C. § 801(a)(2)(A) ON A MAJOR RULE ISSUED BY THE DEPARTMENT OF Health and Human Services, centers for medicare and medicaid services ENTITLED "Medicare Program; End-Stage Renal Disease Prospective Payment System Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS" (RIN: 0938-AT28)
(i) Cost-benefit analysis
The Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) estimated the costs and benefits of this final rule. CMS stated that the finalized revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) will result in an increase of approximately $210 million in payments to ESRD facilities in CY 2019. These payments represent transfers from the federal government to ESRD providers ($160 million) and transfers from beneficiaries to ESRD providers ($50 million). CMS estimates that approximately $40 million will be paid to ESRD facilities for dialysis treatments provided to acute kidney injury beneficiaries.
For payment year (PY) 2021, CMS re-estimated the costs associated with information collection requirements under the ESRD Quality Incentive Program (QIP) for this final rule, and also re-estimated the payment reductions under the ESRD QIP. CMS estimates that these updates will result in an overall impact of $213 million associated with quality reporting burden and payment reductions, which includes a $12 million incremental reduction in burden in collection of information requirements and $32 million in estimated payment reductions across all facilities. In addition, PY 2021 ESRD QIP payment reductions represent transfers from the federal government to ESRD providers of -$32 million, and total ESRD provider costs under the ESRD QIP for PY 2021 total $181 million. For PY 2022, CMS estimated that the proposed revisions to the ESRD QIP will result in an overall impact of $234 million, which includes a $21 million incremental increase associated with the collection of information requirements and $32 million in estimated payment reductions across all facilities. Also, PY 2022 ESRD QIP payment reductions represent transfers from the federal government to ESRD providers of -$32 million, and total ESRD provider costs under the ESRD QIP for PY 2022 total $202 million.
With regard to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS), CMS stated that impacts are generally considered against the Medicare, Medicaid, and beneficiary cost sharing. CMS estimated that the...
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