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Subject

Category: Organ Acquisition

Comments on Proposed Cost Reporting Instructions

July 15, 2022

CMS recently released new proposed Medicare cost reporting instructions, available for download here on the CMS website. Comments are due to CMS by July 22, and can be submitted electronically at this link.

Please see Toyon’s comments on CMS’s proposed cost report instructions here. Additionally, to assist with comments to CMS, providers may download the Hospital | Health System template here. Please review all comments prior to submitting, and feel free to use some or all of the content in this letter. Providers may also amend the language to best articulate comments to CMS using hospital-specific examples, etc.

Toyon comments on the following:

Worksheet S-2 Lines 24 and 25: Medicaid DSH Eligible Days
Worksheet S-2 Line 89: TEFRA Adjustment Date
Worksheet S-2 Line 123: Purchased Administrative Services
Exhibit 2A: Listing of Medicare Bad Debts
Exhibit 3A: Listing of Medicaid Eligible Days for DSH Eligible Hospitals
Worksheet S-10: Financial Assistance Policies
Worksheet S-10: Acute Care Only
Worksheet S-10: Medically Necessary Healthcare
Worksheet S-10: Uninsured Charity Care
Worksheet S-10: Insured Charity Care
Worksheet S-10: Inferred Contractual Relationships
Worksheet S-10: Total Bad Debt
Exhibit 3B (Charity Care Listing)
Exhibit 3C (Listing of Total Bad Debts)

Worksheet S-10 UC DSH

Amongst other proposed revisions, CMS calls for providers to report Uncompensated Care (UC) costs for acute care services only (based on hospital Medicare provider number) on Worksheet S-10 Part II. Please note Section IV of the Hospital | Health System template requests CMS to omit this reporting requirement, as delineating Worksheet S-10 UC cost between acute care and sub-acute care adds another administrative burden to Worksheet S-10 reporting. Toyon acknowledges the reporting of acute care only for UC DSH payments may result in a shift in UC DSH payments for certain hospitals (depending on whether a DSH provider has material charity and bad debt related to subacute providers). Toyon is not commenting on a potential shift in payments, and only focuses on the additional administrative effort of collecting and reporting Worksheet S-10 data.

Organ Acquisition Changes

Toyon is not commenting on CMS’s proposed changes related to Organ Acquisition reporting and reimbursement. Toyon agrees with CMS’s proposed changes, which were also included in the previous PRA package from November 2020. Listed below are CMS’s proposed changes related to Organ Acquisition.

Worksheet A, Lines 78 and 102

CMS is adding lines 78 (CAR T-Cell Immunotherapy) and 102 (Opioid Treatment Program), which will require hospitals to create separate G/L departments to track these expenses and charges. Line 78 is used for reporting IPPS (D-3) and OPPS (D Part V) charges from the PS&R. Line 102 is informational only and is not included in the PS&R charges.

Worksheet D-6 series

This is a new form used to obtain cost-based reimbursement for allogeneic stem cell acquisition costs. CMS made several noteworthy updates to this form from the previous PRA in November 2020. First, there’s no longer a checkbox to include CAR T-Cell acquisition costs in this section which was to be reported for informational purposes only (see comment above for Worksheet A line 78).

Second, the Medicare reimbursement for allogeneic stem cell acquisition costs will now be based on the ratio of Medicare to total transplants, much like the methodology for solid organ. Previously, the form required only to include donor charges for Medicare recipients to determine the Medicare portion. Worksheet D-6 (Part I) now requires hospitals to capture donor charges for all payers. This methodology is a departure from the CMS comments in the FFY 2019 IPPS Final Rule, so CMS may issue a separate rule with comment period for this change.

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Please feel free to share questions to Fred Fisher, fred.fisher@toyonassociates.com. Specific to Organ Acquisition reimbursement, please contact Robert Howey at robert.howey@toyonassociates.com.

CMS Proposes New Cost Reporting Instructions

June 27, 2022

CMS recently released new proposed Medicare cost reporting instructions, available for download here on the CMS website. Comments are due to CMS on July 22, and Toyon will be sharing our comments with more details over the coming weeks.

CMS is proposing notable cost report changes to the following:

Worksheet S-10 Uncompensated Care (UC) reporting for Federal Fiscal Year 2023 (beginning on/after 10/1/2022) and subsequent years.
- Amongst other proposed revisions, CMS proposes a significant change that UC cost represents “only the general short-term hospital inpatient and outpatient services billable under the hospital CMS Certification Number (CCN).”
- CMS proposes a standard Worksheet S-10 data format under Exhibit 3B and Exhibit 3C.
Empirical DSH Medicaid eligible days reported using Exhibit 3A, with applicable instructions to §4004.1 and requirements at 42 CFR 413.24(f)(5)(i)(C) starting with Federal Fiscal Year 2023 cost reports.
Medicare bad debt reporting using Exhibit 2A, with applicable instructions to §4004.2 and requirements at CFR 413.24(f)(5)(i)(B) starting with Federal Fiscal Year 2023 cost reports.
COVID-19 PHE temporary expansion bed reporting. New cost reporting line effective March 1, 2020 through the end of the COVID-19 PHE.
Worksheet D-4 Organ Acquisition updates and additions.
- CMS updates cost reporting instructions to reflect the codification for Medicare organ acquisition payment policies at transplant hospitals as included in FR 73416 (December 27, 2021).
- For cost reporting periods beginning on or after October 1, 2022, CMS proposes providers separately identify revenue for organs sold associated with Medicare Secondary Payer (MSP organs, subscript of line 66) and a separate subscripted line (informational only) for the transplant payment portion.
- For cost reporting periods beginning on or after October 1, 2022, CMS proposes providers separately identify organs transplanted into Medicare beneficiaries, kidneys transplanted into Medicare Advantage (MA) beneficiaries, organs transplanted as Medicare Secondary Payer, and organs transplanted for all other payers (subscript line 75).
Worksheet D-6 Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Acquisition Costs
- CMS proposes further changes to this new worksheet series to calculate inpatient reimbursement for allogeneic stem cell acquisition costs associated with Federal Fiscal Year 2021 cost reports (beginning on or after 10/1/2020).
- CMS proposes to apply key changes (from the initial PRA package issued in November 2020) which include basing payment on the ratio of Medicare transplants to total transplants and reporting all-payer charges related to donors (follows the same methodology as solid organ transplants).

Please feel free to share questions or suggestions for comments to Fred Fisher, fred.fisher@toyonsassociates.com. Specific to organ acquisition, please contact Robert Howey, robert.howey@toyonassociates.com.

Medicare Graduate Medical Education and Organ Acquisition Payment Policy Changes

January 10, 2022

On Monday December 27, CMS published Federal Register / Vol. 86. No. 245 [CMS–1752–FC3. This Final Rule with comment period includes new teaching slots for graduate medical education, modifications to organ acquisition reimbursement, and postpones potential changes related to Section 1115 waiver days for empirical DSH payments. February 25 is the deadline to submit comments to CMS for the issues (discussed below) whereby CMS is seeking feedback.

Graduate Medical Education

CMS’s changes for graduate medical education new teaching slots are directed by legislation provided in the Consolidated Appropriations Act (CAA), 2021. The CAA provides three new opportunities for teaching hospitals: 1) Additional 1,000 FTE cap slots for indirect medical education (IME) and direct graduate medical education (GME); 2) New opportunities for rural training track programs; and 3) Reset of FTE caps or per-resident reimbursement amounts that were established for hospitals using fewer than one or three FTEs, depending on the base year of the existing teaching cap or per-resident amounts. More about these respective changes are detailed below.

1) Additional IME and GME Slots (Section 126 of CAA)

Important Deadline: March 31, 2022 to Apply for Slots in Federal Year 2023

CMS finalized rules on the distribution of 1,000 new resident FTE cap slots over five years (200 per year) under Section 126 of the CAA for hospitals looking to establish or expand residency programs. Hospitals may apply for up to five new FTE cap slots by March 31, 2022 for distribution in Federal Year 2023 (March 31 preceding the federal fiscal year is the deadline for each of the applicable five fiscal years). Further instructions and the application for FTE cap slots will be available on the CMS DGME website.

The additional cap slots will be distributed to hospitals that are included in the following four categories (with at least 10% of slots going to each category):

Hospitals located in rural areas or that are treated as being in a rural area.
Hospitals that are training residents over their cap amount.
Hospitals located in the 35 states (listed in the rule) with new medical schools or additional locations and branches of existing campuses.
Hospitals that train residents in a program where at least 50 percent of the residents’ training time occurs at site(s) physically located in (a) geographic Health Professional Shortage Area(s) (HPSA).

HPSA scores will be a key criterion for all four categories, not just category four. Hospitals can find information about the HPSA or HPSAs associated with their training program locations using the HRSA search tool at: https://data.hrsa.gov/tools/shortage-area/by-address. CMS will prioritize applications by descending HPSA score. When hospitals have the same HPSA score, applications are next prioritized for hospitals with fewer than 250 beds. CMS is seeking comment on the dependence of geographic HPSA residents on health services provided outside of their HPSA, and a feasible alternative for potential use in future rulemaking.

2) Rural Training Track Programs (Section 127 of CAA)

Beginning Federal Year 2023

For cost reporting periods beginning on or after October 1, 2022, non-rural hospitals (“primary clinical sites”) and their rural hospital partners (“rural hospital participation sites”) with “rural track” residency programs may receive resident FTE cap slots. This FTE adjustment is intended to provide flexibility for both rural and urban hospitals focusing on additional physicians in rural markets. In its Final Rule, CMS codified four changes to the rural training track (“RTT”) program rules, as follows:

Each time an RTT program begins or is expanded between an urban and rural hospital, both may receive an adjustment to the FTE resident limit, regardless of whether the RTT program meets the newness criteria for Medicare payment purposes. Eligible expanded programs include new tracks (rural participating sites) added to an existing rural track program, but exclude expansion of existing tracks at an existing rural participating site.
Urban hospitals with existing RTT caps can receive RTT cap adjustments for additional qualifying RTT programs. Rural hospitals would also receive an RTT cap increase.
The requirement that a new rural track must be ‘‘separately accredited” is nullified, provided that the program in its entirety is accredited by the ACGME, and at least 50% of the RTP (“rural track program”) residents’ time is spent in rural areas. If these conditions are met, then it may qualify as an RTT and both hospitals (urban and rural) will receive RTT caps.
RTT program residents will not be included in the hospital’s 3-year rolling average resident cap calculation or subject to the IRB ratio during the build-up period.

3) Hospitals Qualifying to Reset Their PRAs and/or FTE Resident Caps (Section 131 of CAA)

Important Deadline: July 1, 2022 to Correct Medical Education FTE Counts in

CMS’s New (Upcoming) Public Use File

Certain hospitals with low or $0 per resident amounts (PRAs) may reset and establish new PRAs if the hospital trains more than the threshold number of resident(s) in a cost reporting period beginning on or after December 27, 2020 and before December 26, 2025. Certain hospitals with low caps may be eligible for revised FTE caps, if the hospital starts a brand-new program after December 27, 2020. Eligible hospitals fall into two categories:

Category A – hospitals whose PRA and/or resident cap was set based on less than 1.0 FTE in a cost reporting period beginning before October 1, 1997.
Category B – hospitals whose PRA and/or resident cap was established based on training fewer than 3.0 FTEs in a cost reporting period beginning on or after October 1, 1997 and before December 27, 2020.

CMS will post a public use file here on its website containing an extract of the HCRIS cost report worksheets on which the FTE counts, caps, and PRAs, if any, would have been reported, starting with cost reports beginning in 1995. If a hospital wishes to receive a PRA or cap determination from its MAC for a possible reset of an open or reopenable cost report, the hospital must first check the posted public use file. CMS is seeking comment on treatment of PRAs or FTE caps from cost reports beyond the 3-year reopening period that do not agree with data in the forthcoming public use file.

Providers have a one-time deadline of July 1, 2022 to request MAC reconsideration if the provider is a Category B hospital, has an open or reopenable cost report, and believes its PRA in CMS’s public use file is incomplete or incorrect (i.e., FTEs are actually based on not more than 3.0 FTEs, or its IME and/or DGME FTE caps were based on not more than 3.0 FTEs).

Providers qualifying to reset their PRA will establish the replacement PRA resulting from the lower of:

The hospital’s actual cost per resident incurred in connection with the GME program(s) based on the cost and resident data from the hospital’s replacement base year cost reporting period; and
The updated weighted mean value of per resident amounts of all hospitals located in the same geographic wage area, calculated using all per resident amounts (including primary care and obstetrics and gynecology and nonprimary care) and FTE resident counts from the most recently settled cost reports of those teaching hospitals^[1].

Please contact Tom Hubner with questions at 888.514.9312, or tom.hubner@toyonassociates.com.

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^[1] If there are fewer than three existing teaching hospitals with per resident amounts that can be used to calculate the weighted mean value per resident amount, for base periods beginning on or after October 1, 1997, the per resident amount equals the updated weighted mean value of per resident amounts of all hospitals located in the same census region.

Organ Acquisition Payment Policy

CMS finalized their policy regarding Medicare-certified transplant hospitals and non-transplant hospitals’ charges for services to cadaveric donors. CMS also codified and clarified organ acquisition policies, including definitions, acquisition charges, coverage of living donor complications by the Medicare program, Medicare as a secondary payor for organ acquisitions, and paired donations for kidney transplants. The CMS proposal for both organ counting policy and research facility organ counting will be considered in future rulemaking.

The Federal Year 2022 IPPS Proposed Rule contained Section X. of the preamble which included proposed changes pertaining to Medicare’s share of organ acquisition costs for organs transplanted into Medicare beneficiaries and the charges for services provided to cadaveric organ donors by donor community hospitals and transplants hospitals. Listed below are the rules codified by CMS.

Change to Organ Acquisition Policy: CMS finalized the codification and compilation of Medicare organ acquisition policies under a new 42 CFR Part 413 subpart L, which was mentioned in the proposed rule. This new section will include changes to policies and creation of new policies from the Medicare Modernization Act (Pub. L. 108-173) and the 21st Century Cures Act (Pub. L. 114-255). CMS recognizes the need for a more coordinated approach across all organ types (kidney, liver, heart, lung, pancreas, or intestine)^[2].

Clarifying Definitions: CMS will define the term in the new section (42 CFR §413.400) “organ” for Medicare purposes and will exclude organs procured for research. The definition of organ for Medicare payment purposes differs from the definition set forth in 42 CFR §486.302 for Organ Procurement Organizations (OPOs). For Medicare payment purposes, an organ procured for research is not counted as a Medicare organ in Medicare’s share of organ acquisition costs, except where explicitly required by law.

Additional clarification to existing definitions of OPO, hospital-based OPO (HOPO), independent OPO (IOPO), transplant hospital/HOPO (TH/HOPO), and histocompatibility laboratory are added to 42 CFR §413.400.

Organ Acquisition Costs: New Section L will include CFR 42 §413.402(a) specifying costs which are incurred in the acquisition of organs from a living donor or a cadaver by either the hospital or OPO are considered organ acquisition costs. Also, CFR 42 §413.402(b) will codify the 12 elements regarding costs incurred in the acquisition of organs (living/cadaveric by hospital or an OPO) and apply the existing elements of kidney acquisition costs to all organs and include additional revisions that would apply to kidney acquisition only.

Standard Acquisition Charges: CMS also codifies current Medicare policies on Standard Acquisition Charges (SACs) for THs, HOPOs, and IOPOs (CFR 42 §413.404). SACs are amounts that represent the estimated costs that a TH and/or OPO expect to incur during the acquisition of the organ. It is generally the average rather than the actual organ acquisition costs.

Accurate Organ Count (No Current Changes; Medicare and Non-Medicare): CMS, in their proposed rule, suggested revisions to the overall counting of organs used to determine Medicare’s share of organ acquisition costs. CMS planned to follow through with one of two solutions, withdraw the proposal or finalize the proposal but with a delay during the transition period. CMS is not applying changes to organ counting, as further analysis is needed to understand the concerns of all parties. CMS notes changes to organ counting may bear costs that apply to non-Medicare patients.

Please contact Scott Besler with questions at 888.514.9312, or scott.besler@toyonassociates.com.

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^[2] Currently, Medicare reimburses Transplant Hospitals (THs) for organ acquisition costs, the transplant surgery, inpatient, and post-transplant costs for the Medicare recipients, but through different payment systems. Medicare Part A pays for hospital costs of a transplant surgery and certain follow-up care through a DRG payment, and the organ acquisition costs associated with a transplant on a reasonable cost basis. Medicare B pays for the physician and other services related to the procedure.

Section 1115 Demonstration Waiver Days for Empirical DSH Payments

CMS is not currently addressing proposed revisions on the treatment of Section 1115 waiver days for purposes of the DSH adjustment. In the Federal Year 2022 IPPS Proposed Rule, CMS proposed that Section 1115 waiver days can only be claimed in the Medicaid fraction if the patient directly receives inpatient hospital insurance coverage under an approved waiver. This excludes from the Medicaid fraction patient days for which hospitals received a payment from a UC pool. CMS expects to revisit the issue of Section 1115 waiver days in future rulemaking, and encourages stakeholders to review the future proposal and to submit their comments at that time.

Please contact Dylan Chinea with questions at 888.514.9312, ext. 3121, or dylan.chinea@toyonassociates.com

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