This week in Medicare—7/31/2024

Advisory Opinion No. 24-05

On July 22, the OIG published an Advisory Opinion regarding an arrangement in which a publicly traded biotechnology company would cover certain travel and treatment costs for patients who are receiving one of two gene therapy treatments manufactured by the company. Under this arrangement, the requestor would provide financial support to patients who meet specific eligibility criteria so that they can undergo the multiple stages of treatment necessitated by the drugs at an approved hospital treatment center. Along with covering travel costs, the requestor would provide each patient with up to $22,500 for fertility preservation procedures and storage.

The requestor certified that it would not require treating physicians or treatment centers to exclusively use the drugs to be eligible to offer the two forms of financial support. It is seeking an opinion as to whether the arrangement constitutes grounds for the imposition of sanctions under the federal anti-kickback statute or civil monetary penalties related to beneficiary inducements.

The OIG ruled that several aspects of the arrangement would generate prohibited remuneration under the anti-kickback statute and/or beneficiary inducements civil monetary penalty if the requisite intent were present, but only the fertility support component would constitute grounds for the imposition of sanctions.

 

Quarterly Listing of Program Issuances—April through June 2024

On July 22, CMS published a Notice in the Federal Register to provide the regular listing of all notices that were published in the Federal Register in the previous quarter.

 

Fact Sheet on CMS’ Oral Health Cross-Cutting Initiative

On July 23, CMS published a Fact Sheet on its Oral Health Cross-Cutting Initiative, which seeks to improve and expand access to oral healthcare, eliminate persistent oral health disparities, and more. The fact sheet highlights key oral health results across CMS programs and details how coverage has been strengthened through recent policy changes.

 

Advisory Opinion No. 24-06

On July 23, the OIG published an Advisory Opinion regarding an arrangement in which a pharmaceutical manufacturer would finance and coordinate fertility services for patients receiving one of its specific gene therapy products. Under the arrangement, the requestor would finance up to $70,000 in fertility services (e.g., in-vitro fertilization, specimen storage) for patients who meet specific eligibility criteria.

The requester claimed that the arrangement would help these patients receive proper treatment, as many people with the undisclosed conditions chose to forego treatment due to the infertility risks involved and the high cost of fertility preservation services. A third-party vendor would be utilized to coordinate the fertility services, and patients and their caregivers would select their providers and treatments. The requestor is seeking an opinion as to whether the arrangement constitutes grounds for the imposition of sanctions under the federal anti-kickback statute or civil monetary penalties related to beneficiary inducements.

The OIG determined that the arrangement would generate prohibited remuneration under the anti-kickback statute and beneficiary inducements civil monetary penalty if the requisite intent was present, and both circumstances would constitute grounds to impose sanctions.

 

Updating IOM 100-06, Chapter 4, Section 70.16 - Debt Close-Out

On July 24, CMS published Medicare Financial Management Transmittal 12734 to update the debt close-out process in the Medicare Financial Management Manual. Upon receipt of a CMS regional office or Office of General Counsel (RO/OGC) close-out response, contractors are to complete the close-out process by making the necessary adjustments in HIGLAS to formally close out the debt and assign the appropriate accounts receivable write-off status code to end collection activity. Contractors are to complete this process no later than 30 days after receiving the response.

Effective date: August 23, 2024

Implementation date: August 23, 2024

 

Revision to the Cost Report Acceptability Checklists

On July 24, CMS published One-Time Notification Transmittal 12735 to revise the cost report acceptability checklist to include new requirements for Interns and Residents Information System (IRIS) documentation and the CMS 287-22 Home Office Cost Statement.

The previous post-acceptability checklist instructions will now be an independent set of instructions titled “Modified Desk Review.” CMS is in the process of revising the Medicare Financial Management Manual and will include the revised accessibility checklist as an exhibit in chapter 8.

Effective date: October 1, 2024 - Cost Reports Received on or after 10/01/2024

Implementation date: October 1, 2024 - Cost Reports Received on or after 10/01/2024

 

Clarification of Actions to Be Taken When Automated Duplicate Primary Payer (DPP) Claims Cannot Be Processed Due to Previous Secondary Payment Actions and Advanced Dates of Service on Claims

On July 24, CMS published Medicare Secondary Payer Transmittal 12736 to provide guidance to A/B and DME MACs on addressing adjustment requests on DPP claims that were previously processed for secondary payment.

When the MACs receive a DPP claim adjustment request with Claims Processing Indicator “F,” and they determine that they previously processed the claims as secondary, they are to cancel the adjustment and take no further action on the request. When these contractors encounter a claim with a service date of five or more years ago, they are to take manual Medicare Secondary Payer savings on the claim.

Effective date: August 23, 2024

Implementation date: August 23, 2024

 

Utilization Data on Medicare.gov Compare Tool

On July 25, CMS published a Note in MLN Connects to announce the addition of utilization data for the following six new procedures to the Medicare.gov compare tool profile pages for doctors and clinicians:

• Upper endoscopy
• Arthroscopy – upper extremity
• Arthroscopy – lower extremity
• Varicose vein ablation
• Laminectomy/laminotomy (lumbar)
• Lower limb revascularization