This week in Medicare—8/14/2024
Revisions to OPPS Addendum A and B
On August 5, CMS published revised versions of the July 2024 OPPS Addendum A and B files.
Removal of CPT Codes from Prior Authorization List
On August 5, CMS updated its Prior Authorization for Certain Hospital Outpatient Department Services (OPD) webpage to note that it is removing CPT codes 64492 and 64495 for facet joint injections from the prior authorization list. These procedures are no longer covered under LCDs for facet joint interventions, so the prior authorization would always be non-affirmative.
CMS updated the Prior Authorization HCPCS Code List to reflect this change. They are removed effective August 16.
Replacement Wheelchair Equipment When the Manufacturer Exits Wheelchair Business
On August 5, CMS published One-Time Notification Transmittal 12768, which rescinds and replaces Transmittal 12672, dated June 6, to revise the background section clarifying the replacement scenario discussed in this change request does not apply to situations when the wheelchair equipment does not yet need repairs that require replacement parts or when repair / replacement parts (e.g. aftermarket) are available from other sources other than the discontinued manufacturer that can be used to make the wheelchair equipment operable for the reasonable useful lifetime of the equipment.
The original transmittal was published regarding instructions for claims processing for replacement power or manual wheelchairs when the manufacturer either is no longer in business and thus the wheelchair no longer exists on the market or when there’s no availability for aftermarket repair or replacement parts to make the manufacturer’s equipment operable.
Effective date: July 8, 2024
Implementation date: July 8, 2024
Correction Notice: Contract Year 2025 Medicare Advantage and Medicare Prescription Drug Benefit Program Policy and Technical Changes
On August 6, CMS published a Correction Notice in the Federal Register to correct technical and typographical errors from the CY 2025 Medicare Advantage Policy and Technical Changes Final Rule that was published on April 23, 2024.
This correcting amendment is effective August 6, 2024.
Guidance Document: Clinical Endpoints Guidance for Knee Osteoarthritis
On August 7, CMS published a Guidance Document regarding clinical endpoints guidance for knee osteoarthritis. The guidance document identifies health outcomes of interest to CMS when reviewing technologies for treating knee osteoarthritis that may be involved in NCDs. The guidance document itself, however, does not review specific technologies nor is it an NCA or NCD.
This guidance was first proposed in June 2023 and was finalized based on comments received last summer. CMS included a summary of those comments and their responses to it along with the final guidance.
Guidance Document: Coverage with Evidence Development (CED)
On August 7, CMS published a Guidance Document regarding frameworks for more predictable and transparent CED by discussing factors CMS considers in making NCDs using the CED paradigm. This document is based off comments received from a proposed document CMS issued in June 2023. CMS published a summary of those comments and their responses along with the guidance document.
Guidance Document: CMS National Coverage Analysis Evidence Review
On August 7, CMS published a Guidance Document regarding the National Coverage Analysis (NCA) evidence review process. The document details CMS’ process for developing NCAs and discusses what it hopes to achieve through them. This document is based off comments received from a proposed document CMS issued in June 2023. CMS published a summary of those comments and their responses along with the guidance document.
Final Notice: Transitional Coverage for Emerging Technologies (TCET)
On August 7, CMS published a draft copy of a Final Notice regarding the creation of the TCET pathway through the National Coverage Determination (NCD) process to expedite Medicare coverage of certain breakthrough devices. Through this pathway, CMS will initiate NCD processes for devices accepted into the pathway as soon as the device receives FDA marketing authorization. CMS said its goal is to finalize a TCET NCD within six months after the device receives FDA market authorization.
There were a number of changes made to the final notice since the proposed notice was issued back in June 2023. Some of those changes include:
- Incorporating an opportunity for manufacturers to submit a non-binding letter of intent to nominate a potentially eligible device approximately 18-24 months before anticipated FDA marketing authorization
- Clarifying that when manufacturers pursue the TCET pathway for devices where appropriate clinical endpoints are uncertain, CMS may preemptively conduct a clinical endpoints’ review and convene a MEDCAC panel
- Reviewing nominations on a quarterly basis rather than 30 days after submission
CMS published a Fact Sheet on the same date detailing the various provisions for this pathway. The notice was published in the Federal Register on August 12. It is effective August 12.
CMS Announces Resources and Flexibilities to Assist with the Public Health Emergency in the States of Florida, Georgia, and South Carolina
On August 8, CMS published a News Alert to announce additional resources and flexibilities available in response to Hurricane Debby in Florida, Georgia, and South Carolina. CMS detailed the waivers, special enrollment opportunities, dialysis care, DMEPOS replacements, and other resources available for those impacted by the hurricane.
CMS also has a variety of resources posted on its Current Emergencies website.
Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – October 2024 Update
On August 8, CMS published Medicare Claims Processing Transmittal 12774 to update payment files issued to contractors for the October 2024 updates to the MPFSDB. The files are available to download here.
Effective date: January 1, 2024
Implementation date: October 7, 2024
Revisions to State Operations Manual, Appendix PP
On August 8, CMS published State Operations Provider Certification Transmittal 225 regarding updates to regulations and guidance in the manual as a result of the Facility Assessment rule.
Effective date: August 8, 2024
Implementation date: August 8, 2024
New Place of Service (POS) Code 66 – “Programs of All-Inclusive Care for the Elderly (PACE) Center”
On August 9, CMS published Medicare Claims Processing Transmittal 12779 regarding the creation of new POS code 66 for PACE centers. These facilities provide comprehensive medical and social services as part of the PACE program, and CMS currently only expects to use this code for Medicaid.
Effective date: August 1, 2024
Implementation date: January 6, 2025
Updates to the MCS, the VMS, and the CWF Processes to Capture and Further Automate the Medicare Secondary Payer (MSP) Processes
On August 9, CMS published Medicare Secondary Payer Transmittal 12773 to establish functionality in the MCS to apply the CWF MSP information to the claim at a detail level and ensure the CWF MSP information used to adjudicate the claim detail is not altered in MCS history. This functionality should further automate MSP processes.
Effective date: January 1, 2025 – Requirements, Design, and Coding (CWF and MCS); April 1, 2025 – Requirements, Design & Coding, Testing, and Implementation (VMS)
Implementation date: January 6, 2025 – Requirements, Design and Coding (CWF and MCS); April 7, 2025 – Requirements, Design & Coding, Testing, and Implementation (VMS)
Updates of Chapter 1, 2, 3, 4, and 9 in the Medicare Program Integrity Manual, Including Complaint Referral Coordination Between Contractors
On August 9, CMS published Medicare Program Integrity Transmittal 12772 regarding updates to sections within Chapters 1, 2, 3, 4, and 9 in the manual regarding UPIC coordination with the MACs for complain referrals, guidance regarding inputting suppression and exclusion cases to the RACDW, and various other minor updates. All updates are solely related to contractor technical processes and procedures and have no impact on provider or beneficiary populations.
Effective date: September 20, 2024
Implementation date: September 20, 2024
Recovery and Adjustment of Medicare Claims Where the Department of Veteran Affairs (VA) Also Made Payment Using the Medicare Duplicate Payment Process (DP)
On August 9, CMS published Medicare Secondary Payer Transmittal 12780 regarding updates to the Medicare Secondary Payer DP process to handle the recovery of duplicate payments when both Medicare and the VA made payments for the same services.
Effective date: January 1, 2025 - For CWF (requirements/coding/preliminary unit testing); for FISS (design/coding); for MCS (analysis/design/coding); for VMS (analysis & coding); April 1, 2025 – For CWF (testing/implementation); FISS (continued development/testing/implementation); MCS (continued coding/testing/implementation); and VMS (testing & implementation)
Implementation date: January 6, 2025 - For CWF (requirements/coding/preliminary unit testing); for FISS (design/coding); for MCS (analysis/design/coding); for VMS (analysis & coding); April 7, 2025 - For CWF (testing/implementation); FISS (continued development/testing/implementation); MCS (continued coding/testing/implementation); and VMS (testing & implementation)
Medicare and Some Enrollees Paid Substantially More When Stelara Was Covered Under Part D Versus Part B
On August 9, the OIG published a Report regarding how Stelara, a high-cost biologic used to treat certain autoimmune diseases, was paid when covered by Part B versus Part D. Stelara was covered under Part B (when provided in a physician’s office) and Part D (when self-injected at home) from 2016 through 2021. While the cost for Stelara under Part D remained relatively steady during that time (fluctuating between approximately $14,400 and $15,500), the cost for a single injection continually increased under Part D from $17,700 to $25,900. In 2023, when Stelara was no longer covered under Part B, the average Part D cost for Stelara was $32,559.
The OIG said these findings illustrate how differences in the methods used to set drug payment amounts across the various parts of Medicare can result in widely different payment amounts for the same drugs. This has a major effect on expenditures both for Medicare and for out-of-pocket costs for enrollees. The OIG noted that Medicare expenditures for Stelara overall have ballooned from approximately $300 million in 2016 to almost $3 billion in 2023. As CMS and stakeholders continue to look at ways to reduce the cost of drugs, the OIG said reports like these can help provide insight into various payment methodology options and the impact on drug prices.