This week in Medicare—5/15/2024
Comment Request: Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance
On May 6, CMS published a Comment Request in the Federal Register to announce it is opening a public comment period for the second cycle of the Medicare Drug Price Negotiation Program to negotiate maximum fair prices for certain drugs for 2026 and 2027.
Comments are due by July 2.
Fiscal Intermediary Shared System (FISS) User Enhancement Change Request (UECR) - Expiration of a Unique Tracking Number (UTN) on the Prior Authorization (PA) Tracking File
On May 7, CMS published One-Time Notification Transmittal 12625, which rescinds and replaces Transmittal 12549, dated March 19, to clarify that the decision date or PDOS should count as day 1 to calculate the expiration date by revising BRs 13284.1.1 and 13284.1.2 and to add BRs 13284.1.3, 13284.1.4 and 13284.1.5 for UTN action field values other than A (affirmed.) The new business requirements will be implemented with the July release, and the CR will be modified to reflect a split release by updating the effective and implementation dates.
The original transmittal was issued to modify the FISS to set the expiration date of a UTN on the Prior Authorization Detail Screen automatically in order to prevent providers inadvertently using an expired UTN.
Effective date: April 1, 2024 - BRs 13284.1, 13284.1.1, 13284.1.2 and all of 13284.2; July 1, 2024
- Corrected BRs 13284.1.1, 13284.1.2 and new BRs 13284.1.3, 13284.1.4 and 13284.5
Implementation date: April 1, 2024 - BRs 13284.1, 13284.1.1, 13284.1.2 and all of 13284.2;
July 1, 2024 - Corrected BRs 13284.1.1, 13284.1.2 and new BRs 13284.1.3, 13284.1.4 and 13284.5
Proposed Rule: Alternative Payment Models and the Increasing Organ Transplant Access (IOTA) Model
On May 8, CMS published a draft copy of a new Proposed Rule to create an alternative payment model, the IOTA Model, which aims to increase the number of people receiving kidney transplants while improving quality of care and creating a patient-centered transplant process. The model would be a six-year mandatory model that would begin on January 1, 2025.
CMS would select half the donation service areas (DSA), and all eligible kidney transplant hospitals in those areas would be required to participate in the model. The other half of DSAs would serve as the control group for evaluation purposes. Transplant hospitals would receive performance scores based on achievement, efficiency, and quality domains. Depending on performance in those domains, hospitals would either receive upside risk payments from CMS, fall into a neutral zone where they neither receive payments from nor owe payments to CMS, or would owe downside risk payments to CMS. The maximum positive payment per transplant under the model would be $8,000, while the maximum negative payment per transplant would be $2,000.
CMS published a Fact Sheet, Press Release, and Webpage on the proposed model. The rule about the model is scheduled to be published in the Federal Register on May 17, and comments will be due 60 days after the date of that publication.
Request for Information: The Role of Patient Selection Criteria in Ensuring Equitable Access to Kidney Transplantation
On May 8, the OIG published a Request for Information regarding a study on the role of patient selection criteria in ensuring equitable access to kidney transplantation. The OIG is having Medicare-participating adult kidney transplant programs submit their written patient selection criteria and information about the population of patients evaluated for a deceased donor kidney transplant in CY 2023. It will be contacting some programs for a second time to obtain additional information about a sample of patients from this population.
ICD-10 and Other Coding Revisions to NCDs—October 2024
On May 9, CMS published One-Time Notification Transmittal 12626 regarding the October quarterly update of the ICD-10 coding conversions and other coding updates specific to NCDs. The NCDs affected by this round of updates include NCD 90.2 (Next Generation Sequencing), NCD 100.1 (Bariatric Surgery for Treatment of Co-Morbid Conditions Related to Morbid Obesity), and NCD 110.18 (Aprepitant for Chemotherapy-Induced Emesis).
CMS published MLN Matters 13596 to accompany the transmittal.
Effective date: As indicated in individual BRs
Implementation date: June 10, 2024 – BRs 2, 3, and 1 (0448U only); July 1, 2024 – BR 1 (0473U only)
Quarterly Update to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)
On May 9, CMS published Medicare Claims Processing Transmittal 12628 regarding the implementation of the transitional drug add-on payment adjustment (TDAPA) for the new HCPCS code J0911 (instillation, taurolidine 1.35 mg and heparin sodium 100 units [central venous catheter lock for adult patients receiving chronic hemodialysis]). The transmittal also updates the list of outlier services under the ESRD PPS.
CMS published MLN Matters 13608 to accompany the transmittal.
Effective date: July 1, 2024
Implementation date: July 1, 2024
Quarterly Update to the Medicare Physician Fee Schedule (MPFSDB) – July 2024 Update
On May 9, CMS published Medicare Claims Processing Transmittal 12629 regarding the quarterly updates to the MPFSDB. The new file should be available to download by May 17.
Effective date: January 1, 2024
Implementation date: July 1, 2024
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS) NCD 110.23
On May 9, CMS published Medicare Claims Processing Transmittal 12627 and Medicare National Coverage Determinations Transmittal 12627 regarding the expanded coverage for allogeneic HSCT using bone marrow, peripheral blood, or umbilical cord blood stem cell products for Medicare patients with MDS. CMS issued a final decision regarding this expanded coverage in March 2024.
CMS published MLN Matters 13604 to accompany the transmittal.
Effective date: March 6, 2024
Implementation date: October 7, 2024
Part B Drug Payment Limits Overview
On May 9, CMS published a Resource on Part B drug payments to review the average sales price payment limit calculation and other Part B drug payment methodologies. The resource is a two-page PDF with short descriptions of each pricing term and how that element is used in calculations for payment limits.
Health Equity-related Data Definitions, Standards, and Stratification Practices
On May 9, CMS published a Resource covering various health equity-related data definitions, the standards for that data, and an FAQ section. CMS said the resource can be used by anyone looking to harmonize with CMS when collecting, stratifying, and/or analyzing health equity-related data, and it may clarify differences in results that could come from different data standards and definitions.
Medical Review Policies for Signature Requirements
On May 9, CMS published Medicare Program Integrity Transmittal 12633 regarding clarifications for medical review policies for signature requirements. This applies to both prior authorization and regular medical review processes.
CMS revised sections in the manual pertaining to how the contractors should handle instances where a signature is required by statute/regulation/NCD/LCD as well as situations where signatures are not required. It also discusses electronic signatures, signature attestation statements, and more.
Effective date: June 10, 2024
Implementation date: June 10, 2024
Potential Vulnerabilities in CMS Oversight of Medicare Add-On Payments for COVID-19 Tests Show That Oversight Could Be Improved
On May 10, the OIG published a Data Brief regarding potential vulnerabilities in CMS’ oversight of COVID-19 add-on payments for tests done between January 2021 through June 2022. The add-on payment was available for laboratories which completed the testing within a specific turnaround time. The OIG found that 68% of laboratories that billed Medicare at least once for the add-on payment during the audit period billed for that payment with all COVID-19 tests. The OIG said there were two potential vulnerabilities with CMS oversight for these payments:
- CMS requirements related to supporting documentation for add-on payments were vague and laboratory documentation was inconsistent
- CMS and MACs did not perform adequate reviews of claims for add-on payments
The OIG shared the data brief with CMS, but CMS did not have any comments on it.
Revisions to State Operations Manual, Chapter 10 – Informal Dispute Resolution (IDR) and Enforcement Procedures for Home Health Agencies and Hospice Programs
On May 10, CMS published State Operations Provider Certification Transmittal 221 regarding revisions to the manual to provide procedures for the IDR process for both home health agencies and for hospices. The revisions also include guidance for the state agencies and the CMS Survey & Operations Group Locations on recommending and imposing HHA alternative sanctions and hospice enforcement remedies.
Effective date: May 10, 2024
Implementation date: May 10, 2024
Implement Edits on Hospice Claims
On May 10, CMS published One-Time Notification Transmittal 12636, which rescinds and replaces Transmittal 12330, dated October 26, 2023, to revise the background section and the implementation date to include June 3, 2024, and to revise BR 13342.4 to reflect this date change.
The original transmittal was issued regarding the implementation of edits on hospice claims in accordance with a requirement where certified physicians must be enrolled in or opted-out of Medicare for the hospice service to be paid.
Effective date: May 1, 2024 – policy effective date
Implementation date: April 1, 2024; June 3, 2024 – target implementation date
Additional Implementation Edits on Hospice Claims for Hospice Certifying Physician Medicare Enrollment
On May 10, CMS published Medicare Claims Processing Transmittal 12365, which rescinds and replaces Transmittal 12586, dated April 19, to change the effective date, revise the background section and BR 13531.3, update BR 13531.2 to include the new date when the editing will apply, and add a note to BR 13531.4.
The original transmittal was published to implement additional edits on Hospice Claims for Hospice Certifying Physician Medicare Enrollment.
CMS revised MLN Matters 13531 on the same date to accompany the transmittal.
Effective date: June 3, 2024
Implementation date: October 7, 2024