This week in Medicare—11/1/2023
Updated EUA for Lagevrio (molnupiravir) as a COVID-19 Treatment
On October 17, CMS updated its New COVID-19 Treatments Add-On Payment (NCTAP) webpage to note that the FDA updated the EUA for Lagevrio (molnupiravir) on October 3. The EUA now states that the US government will no longer direct the distribution of the product and says that while Paxlovid is an acceptable alternative for Lagevrio, the conditions of the EUA for Lagevrio continue to be met.
Implementation of Rural Emergency Hospital (REH) Provider Type
On October 18, CMS published Medicare Claims Processing Transmittal 12321, which rescinds and replaces Transmittal 11900, dated March 13, to clarify the REH monthly facility amount and provider reporting in the policy section and to add business requirement 12820.26. The original transmittal was issued regarding the implementation of the system requirements necessary for the REH provider type.
Effective date: January 1, 2023
Implementation date: January 3, 2023
Processing Claims When the Dates of Service are Beyond the Time Limit for the Patient Assessment
On October 19, CMS published Medicare Claims Processing Transmittal 12306 regarding instructions to home health agencies, inpatient rehabilitation facilities, and MACs regarding situations when claims are payable but the corresponding patient assessment cannot be submitted. The policy isn’t new, but CMS included an in-depth explanation of how to handle these situations in the manual.
CMS published MLN Matters 13402 to accompany the transmittal.
Effective date: January 24, 2024
Implementation date: January 24, 2024
FISS User Enhancement Change Request (UECR) – Expiration of a Unique Tracking Number (UTN) on the Prior Authorization (PA) Tracking File
On October 19, CMS published One-Time Notification Transmittal 12309 to modify the FISS to set the expiration date of a UTN on the Prior Authorization Detail Screen automatically in order to prevent providers from inadvertently using an expired UTN. The transmittal also formally implements directions to instruct the MACs to set the medical review units on the PA program file for certain outpatient services.
Effective date: April 1, 2024
Implementation date: April 1, 2024
ICD-10 and Other Coding Revisions to National Coverage Determinations (NCD)—April 2024 Update
On October 19, CMS published One-Time Notification Transmittal 12318 (1 of 2) regarding the quarterly updates to ICD-10 coding conversions and other coding updates specific to NCDs. Affected NCDs include NCD 20.4 (Implantable Cardiac Defibrillators), NCD 20.9.1 (Ventricular Assist Devices), NCD 20.16 (Cardiac Output Monitoring by Thoracic Electrical Bioimpedance (TEB), and more.
Effective date: April 1, 2024
Implementation date: November 21, 2023 – Requirements 2, 4, 11; April 1, 2024 – unless otherwise indicated in individual business requirements
On October 19, CMS published One-Time Notification Transmittal 12319 (2 of 2) regarding the quarterly updates to ICD-10 coding conversions and other coding updates specific to NCDs. Affected NCDs include NCD 160.18 (Vagus Nerve Stimulation), NCD 160.24 (Deep Brain Stimulation), NCD 190.3 (Cytogenetic Studies), and more.
Effective date: April 1, 2024 – unless otherwise indicated in individual business requirements
Implementation date: November 21, 2023 – BRs 2, 6, 7, 12 – MACs; January 2, 2024 – BR 11; April 1, 2024 – unless otherwise indicated in individual business requirements
Updated FAQs on JW and JZ Modifiers
On October 19, CMS updated an FAQ on the JW and JZ modifiers to clarify billing policies for these modifiers. Updated FAQs include #7-8 and #18-22. Questions 7-8 address billing codes and which drugs are included in the policy while questions 18-22 address settings in which these modifiers apply.
CMS also published a new List of billing and payment codes only used for single-dose containers that may require the modifiers depending on the setting. CMS said it plans to update the list semi-annually, but the list does not include all drugs subject to the JW and JZ modifier policy.
Complying with Medical Record Documentation Requirements
On October 19, CMS updated an MLN Fact Sheet regarding compliance with medical record documentation requirements. The updates provide examples of documentation that would support medical necessity and can be submitted as part of a CERT review.
FISS UECR – New Reason Code to Prevent Adjustments and Cancels from Being Submitted for the Same Claim on the Same Day
On October 20, CMS published One-Time Notification Transmittal 12310 regarding the creation of a new reason code to assign when a provider submits a cancel and adjustment for the same claim in the same cycle.
Effective date: April 1, 2024
Implementation date: April 1, 2024
OIG Advisory Opinion No. 23-08
On October 25, the OIG published an Advisory Opinion regarding a proposed arrangement where cochlear implant manufacturer would offer/provide free hearing aids to certain patients (including federal health care program beneficiaries) who receive one of the cochlear implants the company manufactures. The requestor was seeking an opinion as to whether this arrangement would constitute grounds for the imposition of sanctions under the exclusion authority or civil monetary penalty provisions related to the anti-kickback statute or prohibition on beneficiary inducements.
The OIG said this arrangement would constitute grounds for the imposition of sanctions under both the anti-kickback statute and the prohibition on beneficiary inducements. The issues are described fully in the opinion, but some of the reasons the OIG gave as to why it ruled unfavorably in this case include that the requestor would be providing remuneration in the form of a free hearing aid that may induce patients to order and purchase a device reimbursable by federal health care programs; the value of the hearing aid exceeds the cap provided in the safe harbor for arrangements for patient engagement and support; the arrangement could cause unfair competition in the hearing aid market, and more.
Update to the Claims Processing Manual, Chapter 23 (Fee Schedule Administration and Coding Requirements), Section 50.6
On October 26, CMS published Medicare Claims Processing Transmittal 12326 regarding updates to manual language to specify that certain indicators do not apply to CAH claims.
Effective date: January 29, 2024
Implementation date: January 29, 2024
Implement Edits on Hospice Claims
On October 26, CMS published One-Time Notification Transmittal 12330 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
Implementation date: April 1, 2024
Medicare Secondary Payer: Don’t Deny Services & Bill Correctly
On October 26, CMS revised an MLN Fact Sheet regarding billing Medicare as a secondary payer. The updates added information on ORM indicators and added a section about billing in liability insurance situations.
Final Rule: CY 2024 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)
On October 27, CMS published a draft copy of the CY 2024 ESRD PPS Final Rule. CMS finalized policies including a payment adjustment that will increase payment for certain new renal dialysis drugs and biological products for three years after the Transitional Drug Add-on Payment Adjustment (TDAPA) period ends. The TDAPA period currently lasts for two years, and this new payment adjustment will extend increased payment for a total of five years. The payment will be case-mix adjusted and set at 65% of estimated expenditure levels for the drug or biological from the previous year. Some of the other policies finalized in the rule include:
- Requirement of reporting “time on machine” data and reporting discarded and unused amounts of certain single-use renal dialysis drugs and biologicals on ESRD PPS claims using the JW/JZ modifiers
- Three clarifications regarding the evaluation of the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) eligibility criteria
CMS estimates payment updates in the rule will increase ESRD payments for freestanding clinics by 2.0% and increase payments for hospitals by 3.1%. The final CY 2024 ESRD PPS base rate is $271.02.
CMS published a Fact Sheet on the rule on the same date. These regulations are effective January 1, 2024.