This week in Medicare updates—6/28/2023
Home Dialysis Payment Adjustment (HDPA) and Performance Payment Adjustment (PPA) for End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model: Updated Process
On June 13, CMS revised MLN Matters 13180 to delete references to condition codes 74 and 76. The original article was published on May 4 to accompany Medicare Demonstrations Transmittal 12020 regarding a correction to a process for adjusting ESRD ETC model payments. There are two payment adjustments: the HDPA and the PPA. This transmittal creates a field that enables the process for the PPA.
Effective date: October 1, 2023
Implementation date: October 2, 2023
FDA Approval of Paxlovid to Treat Adult Patients with COVID-19
On June 20, CMS updated its New COVID-19 Treatments Add-On Payment webpage to note that the FDA approved Paxlovid for use in eligible adult patients effective May 25. Paxlovid remains under an EUA when treating eligible pediatric patients. The FDA updated a Fact Sheet for healthcare providers to accompany the approval.
Paxlovid was one of the treatments eligible for NCTAP, a program that ends September 30.
Provider Education for the Review Choice Demonstration (RCD) for Inpatient Rehabilitation Facility Services (IRFs)
On June 22, CMS published One-Time Notification Transmittal 12093 regarding instructions to the JJ MACs to provide education for IRF providers regarding the RCD process for IRFs who are physically located in and bill to Alabama. The MACs will then expand this process to IRFs who bill in all states in the JJ jurisdiction. The transmittal includes a sample letter demonstrating what provider education should include.
Effective date: July 25, 2023
Implementation date: July 25, 2023
Notice with Comment: Transitional Coverage for Emerging Technologies (TCET)
On June 22, CMS published a draft copy of a Notice with Comment Period on the creation of the TCET pathway through the National Coverage Determination (NCD) process to expedite Medicare coverage of certain breakthrough devices. The voluntary pathway aims to balance early access to new technologies with patient safety while also helping to facilitate evidence development where any evidence gaps exist. CMS stated that coverage under this pathway would likely last for three to five years and would include requirements such as the creation of an evidence development plan (EDP), evidence previews, intermittent EDP updates, and more.
CMS published a Fact Sheet on the same date detailing the various provisions for this pathway. The notice is scheduled to be published in the Federal Register on June 27, and comments will be due 60 days after that.
CMS Announces New Details of Plan to Cover New Alzheimer’s Drugs
On June 22, CMS published a Fact Sheet regarding Medicare coverage of new Alzheimer’s drugs and the creation of a registry to help collect evidence about how these drugs work. The fact sheet follows up on an NCD issued on April 7, 2022, which provided coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. CMS is now creating its own registry for these drugs and is working with multiple organizations to prepare other registries. The fact sheet discusses the information providers will be required to submit to the registration, how to submit information, and more.
CMS’ Oversight of Medicare Payments for the Highest Paid Molecular Pathology Genetic Test Was Not Adequate to Reduce the Risk of Up to $888 Million in Improper Payments
On June 23, the OIG published a Review of whether CMS’ oversight of Medicare payments for CPT code 81408 (molecular pathology procedure, level 9) was adequate to reduce the risk of improper payments. The OIG was looking into this code because through 2016-2019, the code had the second-highest total Part B payments, and it receives the highest Medicare payment amount ($2,000) for molecular pathology procedures. The code is generally billed when testing for multiple genes associated with rare diseases, which generally manifest in childhood and therefore would not frequently be associated with the Medicare population.
The OIG found that MAC oversight of Medicare payments for CPT code 81408 failed to ensure that all Medicare enrollees had established relationships with ordering providers, did not ensure that Medicare payments for this CPT code were related to diseases associated with genes tested and billed under 81408, and did not include adequate monitoring of the number of tests billed under that code (a Tier 2 code) to determine whether that number exceeded the number of tests billed under Tier 1 codes. While five of seven MACs had Local Coverage Article guidance limiting the use of 81408, two MACs did not limit its use. Those two MACs’ payments made up 97% of the total payments for this code.
At the end of the OIG’s audit period, those two MACs issued new Local Coverage Article guidance significantly limiting the use of the code. The OIG, therefore, considers the issues identified by the audit to be resolved, but it issued recommendations to CMS to review claims billed under 81408 during the audit period, determine any improper payments for these claims, recover payments for any claims in the re-opening period, and notify appropriate providers so the providers can return any overpayments in accordance with the 60-day rule. CMS concurred with some recommendations and did not state whether it concurred or did not concur with the remaining recommendations.
OPPS Addendum A and Addendum B Updates
On June 23, CMS published Download Links for the July 2023 versions of the OPPS Addendum A and Addendum B files.