This week in Medicare—11/27/2024
Local Coverage Determination Issued for Treatment of Diabetic Foot (DFU) and Venous Leg Ulcers (VLU)
On November 14, CMS announced the MACs published an LCD on skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of DFUs and VLUs. The LCD states that despite the lack of definitive improved health outcomes in the Medicare population, coverage will be provided for skin substitute grafts and CTPs that have peer-reviewed, published evidence supporting their use as advanced treatment for chronic ulcers that have failed prior established methods for healing. There are many changes between the final policy and the proposed policy; these changes are detailed in the LCD policy.
Expired QSO Memorandums Regarding Transplant Services
On November 18, CMS updated several QSO memorandums pertaining to transplant services to note those memorandums have now expired. These include:
- Survey and Approval of Pancreas and Intestine Transplant Centers (QSO-19-05)
- Transplant Centers: Citation for Outcome Requirements: (SC-17-13)
- Solid Transplant Programs-Outcome Thresholds-Revised Guidelines (SC-16-24)
- Transplant Centers: Clinical Experience Requirements (SC-17-04)
The expiration date for all of these memos is November 18, 2024.
Revised Long-Term Care (LTC) Surveyor Guidance: Significant Revisions to Enhance Quality and Oversight of the LTC Surveyor Process
On November 18, CMS published a Memorandum to state survey agency directors regarding revised surveyor guidance and associated training and resources for nursing home surveyors. The guidance applies to topics such as admission, transfer, and discharge; chemical restraints/unnecessary psychotropic medication; resident assessments; and more.
Effective date: Surveyors will be using this guidance to determine compliance with requirements on surveys beginning on February 24, 2025.
Updated Notice of Medicare Non-Coverage and Detailed Explanation of Non-Coverage Notice
On November 18, CMS published updated versions of the Fee-for-Service and Medicare Advantage Notice of Medicare Non-Coverage and Detailed Explanation of Non-Coverage forms, which are available for download on the CMS website.
For Medicare Advantage, CMS published a revised version of the Notice of Denial of Medical Coverage, which is also available for download on the CMS website. In addition, the NOMNC has been modified to reflect regulations providing enrollees additional fast-track appeal rights when they request an appeal in an untimely manner to the BFCC-QIO. The DENC has also been update to include a new element for health plans to complete about repeat appeals within the same episode of care.
For all of these forms, hospitals and health plans must use the current notices until December 31, 2024, and they are required to use the new notice beginning January 1, 2025.
Medicare Improperly Paid Acute Care Hospitals an Estimated $190 Million Over Five Years for Outpatient Services Provided to Hospice Enrollees
On November 18, the OIG published a Review of whether Medicare payments to acute care hospitals for outpatient services provided to hospice enrollees complied with Medicare requirements. The audit looked at a random sample of 100 line items from payments for outpatient services billed with condition code 07 and provided to hospice enrollees between 2017 through 2021.
The OIG found that payments for 70 of the 100 line items did not comply with Medicare requirements, as Medicare paid acute care hospitals for outpatient services that palliated or managed hospice enrollees’ terminal illnesses. These services are covered as part of the hospices’ per diem payments and therefore the acute care hospitals should not be receiving payment from Medicare for them.
On the basis of the sample, the OIG estimates that Medicare could have saved $190.1 million during the audit period if payments had not been made improperly, and enrollees could have saved $43.6 million in deductibles and coinsurance that may have been incorrectly collected. The OIG recommends CMS improve system edit processes to help reduce these improper payments, educate acute care hospitals on how to determine which services are related to the terminal illness, clarify Medicare guidance on the topic, and more. CMS concurred with all recommendations except the recommendation on improving system edit processes, as it said it has feasibility and effectiveness concerns about the initial OIG recommendation on edits.
2024 HHS-OIG Top Management and Performance Challenges
On November 18, the OIG released its 2024 Top Management and Performance Challenges report. The challenges pertaining to CMS included minimizing fraud/waste/abuse, improving quality and safety in nursing homes, strengthening oversight of managed care programs, and fostering equitable access to high quality care.
Guidance for Time-Share and Leased Space Arrangements in Critical Access Hospitals (CAH)
On November 20, CMS published a Memorandum to state survey agency directors regarding guidance meant to clarify expectations related to space sharing arrangements (including time-sharing and leased space) between CAHs and other health care entities. The guidance discusses whether the CAH is responsible for demonstrating compliance with the Conditions of Participation within the leased space.
Effective date: Immediately. This policy should be communicated with all survey and certification staff, their managers, and the CMS location training coordinators of this memorandum.
Nursing Facility Industry Segment—Specific Compliance Program Guidance
On November 20, the OIG published a webpage containing the Industry Segment-Specific Compliance Program Guidance for nursing facilities. The page contains a link to download the guidance book in its entirety and also links out to the individual sections within the compliance guide.
Revised: Revisions to Appendix Q: Guidance on Immediate Jeopardy
On November 21, CMS published a Revised Memorandum, which was originally published on March 5, 2019, regarding updates to Appendix Q of the State Operations Manual about immediate jeopardy as it pertains to laboratories. The revisions move certain information for laboratories from Appendix Q to a new subpart XI in the manual, and it also clarifies information about how laboratories should handle immediate jeopardy situations.
Effective date: Immediately. Please communicate to all appropriate staff within 30 days.
April 2025 Biannual Update of ICD-10-CM
On November 21, CMS published Medicare Claims Processing Transmittal 12978 regarding the April 2025 biannual update of the ICD-10-CM code set. The transmittal instructs the contractors to download the code set files when they become available in February and provide directions on how to upload them into the system to prepare for claims processing.
Effective date: April 1, 2025
Implementation date: April 7, 2025
Requirements for Adjusting/Demanding and Reporting OIG Identified Overpayments
On November 21, CMS published Medicare Financial Management Transmittal 12968 regarding instructions to contractors on how to handle requirements to adjust/demand overpayments based on OIG audits and how to report any collections related to these overpayments.
Effective date: December 23, 2024
Implementation date: December 23, 2024
Manual Update for Pneumococcal Vaccine for 21-Valent Conjugate Vaccine
On November 21, CMS published Medicare Claims Processing Transmittal 12974 regarding updates to various sections of the Claims Processing Manual to add information about the 21-valent pneumococcal vaccine, which will be reported with HCPCS code 90684.
Effective date: June 17, 2024
Implementation date: February 26, 2024
Summary of Policies in the CY 2025 MPFS Final Rule
On November 21, CMS published Medicare Claims Processing Transmittal 12975 regarding the implementation of policies from the CY 2025 MPFS final rule. It includes changes to policies regarding telehealth, caregiver training, therapy, advanced primary care management, global surgery payment, dental and oral health, cardiovascular risk assessment and management, E/M services, and behavioral health.
CMS published MLN Matters 13887 on the same date to accompany the transmittal.
Effective date: January 1, 2025
Implementation date: January 6, 2025
April 2025 Update to the IPPS for Correction to Total Pass-Through Amounts Reporting on the Provider Specific File (PSF) to Include Allogeneic Stem Cell Costs
On November 21, CMS published Medicare Claims Processing Transmittal 12976 regarding instructions to the MACs to include the pass-through amounts for allogeneic stem cell costs in the total pass-through amount field of the inpatient PSF. It also updates the IPPS cloud pricer to ensure the total pass-through per diem amounts are populated correctly when calculating payment for Medicare Advantage claims using the online estimating tool.
Effective date: October 1, 2020 – for cost reporting periods beginning on or after October 1, 2020
Implementation date: April 7, 2025
Medicare Change of Status Notice (MCSN) Manual Instructions
On November 21, CMS published Medicare Claims Processing Transmittal 12934 regarding updates to the manual to implement guidance for expedited determination when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.
This policy was implemented through the final rule on Medicare Appeals Rights for Certain Changes in Patient Status, which was published in the Federal Register in October. The implementation date for the MCSN and new appeals process is February 14, 2025.
On November 22, CMS published MLN Matters 13846 to accompany the transmittal.
Effective date: November 15, 2024 – 30 days after regulation publication date
Implementation date: February 14, 2025
On November 27, CMS added a Webpage to its Beneficiary Notices Initiative section to provide information about the MCSN.
Implementation of System Changes for the End Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury (AKI) for CY 2025
On November 22, CMS published Medicare Claims Processing Transmittal 12979, which rescinds and replaces Transmittal 12957, dated November 22, to correct the LVPA tier adjustment factors in the CR policy language.
CMS revised MLN Matters 13686 to accompany the transmittal.
Effective date: January 1, 2025
Implementation date: January 6, 2025