This week in Medicare updates—7/28/2021

July 28, 2021
Medicare Insider

Renewal of COVID-19 PHE

On July 19, ASPR published a Notice announcing that the COVID-19 PHE has been extended effective July 20, 2021. This will extend the PHE and all applicable waivers tied to it for an additional 90 days.


National Coverage Determination (NCD) Removal

On July 19, CMS published Medicare National Coverage Determinations Transmittal 10888which rescinds and replaces Transmittal 10838, dated June 8, 2021, to remove FISS RC 32440 from NCD 220.6.16 FDG PET attachment and from BR 12254.4. The original transmittal was published regarding the removal of six NCDs from the NCD manual.

CMS revised MLN Matters 12254 on the same date to accompany the transmittal.

Effective date: January 1, 2021

Implementation date: June 22, 2021; October 4, 2021


Replacing Home Health Requests for Anticipated Payment (RAPs) with a Notice of Admission (NOA) -- Implementation 

On July 19, CMS published One-Time Notification Transmittal 10890which rescinds and replaces Transmittal 10795, dated May 20, 2021, to revise HIGLAS related BRs 12227.5.1 - 12227.5.7 and to add new BRs 12227.5.4.1 and 12227.5.8. The original transmittal was published regarding the implementation of the one-time Notice of Admission submission instead of submitting a RAP for every home health period of care. 

Effective date: January 1, 2022 - Claims from dates on or after this date

Implementation date: October 4, 2021 - for FISS & CWF requirements, design and coding; January 3, 2022 - for FISS and CWF additional coding, testing and implementation, and for all HIGLAS changes; April 4, 2022 - for CWF changes to HICR under BR 12227.6 


2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Prospective Payment System (ASC PPS) Proposed Rule

On July 19, CMS published a draft copy of the 2022 OPPS and ASC PPS Proposed Rule, which is scheduled to be published in the Federal Register on August 4. CMS is proposing to reverse course on the removal of the inpatient-only list, a process which was finalized in the 2021 OPPS final rule, and instead proposes adding the 298 services removed from the list in CY 2021 back into the inpatient-only list for CY 2022. The rule proposes updates to both OPPS and ASC PPS payment rates by 2.3% for 2022. Other proposals in the rule include:

  • Increasing civil monetary penalties for failure to comply with price transparency requirements by using a scaled approach based on bed counts for the fines
  • Maintaining payment for 340B drugs at ASP minus 22.5%
  • Reinstating criteria relating to patient safety for adding procedures to the ASC covered procedures list and removing 258 of the 267 procedures added to the list under the policy that had been implemented via the 2021 OPPS final rule
  • Using CY 2019 data to set CY 2022 OPPS and ASC payment system rates

CMS is seeking comments on a variety of topics within the rule, including how best to establish rural emergency hospitals as required by the Consolidated Appropriations Act of 2021, how to reduce burden in compliance with the price transparency requirements, whether to extend or make permanent certain flexibilities granted during the COVID-19 PHE, and more. Comments are due within 60 days after the date of filing for public inspection.  

CMS published a Fact Sheet and Press Release on the rule on the same date.  


Advisory Opinion No. 21-09

On July 19, the OIG published an Advisory Opinion regarding whether the OIG would impose sanctions under the federal anti-kickback statute and prohibition on beneficiary inducements civil monetary penalty due to an arrangement in which a Medigap plan would contract with a preferred hospital organization (PHO) and would have network hospitals under the PHO provide discounts to the Medigap plan on policyholders’ Part A inpatient deductibles. The discount would be established in advance and would be applied uniformly to all policyholders for at least one year. The Medigap plan would then offer a $100 premium credit to policyholders who select a network hospital under the PHO for a Part A covered inpatient stay. This credit would apply to the next premium payment due to the policyholder’s Medigap plan after the inpatient stay. The Medigap plan would also pay the PHO a monthly, percentage-based administrative fee to compensate the PHO for establishing the hospital network and arranging for network hospitals to discount the Part A inpatient deductible. 

The OIG determined that all three streams of remuneration in this agreement would implicate the anti-kickback statute, and the premium credit from the Medigap plans to the policyholders would implicate the beneficiary inducements civil monetary penalty. However, the OIG said it would not impose sanctions in this case due to a low risk of fraud and abuse. The OIG said several elements of the arrangement factored into its decision, and it discussed these factors in depth in the Opinion.


FDA Issues Emergency Use Authorization (EUA) For Monoclonal Antibody Treatment, Tocilizumab 

On July 20, CMS updated its Monoclonal Antibody COVID-19 Infusion page with information on billing and coding for a new monoclonal antibody product, Tocilizumab (brand name Actemra). This product received an EUA from the FDA as a treatment for severe COVID-19 in hospitalized adult and pediatric patients over the age of 2 who are receiving systemic corticosteroids and require supplemental oxygen, ECMO, or mechanical ventilation. The EUA is effective June 24. 

Providers should report Q0249 for the product, M0249 for the first administration, and M0250 for the second administration. The government will not provide the drug for free. The payment allowance for Q0247 is $6.572. Payment for the first administration (M0249) will be $450, and payment for the second administration will also be $450.

CMS also added billing, coding, and payment information about Tocilizumab on its COVID-19 Vaccines and Monoclonal Antibodies webpage and published a link to the FDA Fact Sheet on the treatment.  


NCD 110.24: Chimeric Antigen Receptor (CAR) T-Cell Therapy 

On July 20, CMS published Medicare National Coverage Determination Transmittal 10891 and Medicare Claims Processing Transmittal 10891 which rescind and replace Transmittals 10796, dated May 20, 2021, to add CPT code C9076 for Breyanzi and the HCPCS website for reference to the policy section and in the 100-04 manual attachment. It also updates the implementation date and updates BRs 12177-04.1, 12177-04.3, 12177-04.4, and 12177-04.8. This correction only revises the Claims Processing Manual.  The transmittals were issued regarding coverage of CAR T-Cell Therapy.

CMS revised MLN Matters 12177 on the same date to accompany the transmittal. 

Effective date: August 7, 2019

Implementation date: September 20, 2021


Updated Corporate Integrity Agreement Documents

On July 21, the OIG published information on a new Corporate Integrity Agreements with the following entity:


Comment Request: Medicare Prescription Drug Benefit Program; Conditions of Coverage for Portable X-ray Suppliers and Supporting Regulations

On July 21, CMS published a Comment Request in the Federal Register regarding the following information collections:

  • Medicare Prescription Drug Benefit Program
  • Conditions of Coverage for Portable X-ray Suppliers and Supporting Regulations

Comments are due by September 20.


Comment Request: CAHPS Survey for MIPS; ICD-10-PCS; more

On July 21, CMS published a Comment Request in the Federal Register regarding the submission of the following information collections for OMB review:

  • The International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS)
  • Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System
  • Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey for Merit-based Incentive Payment Systems (MIPS)

Comments are due by August 20.


Additional Payment Edits for DMEPOS Suppliers of Custom Fabricated and Prefabricated (Custom Fitted) Orthotics, Update to Change Requests 3959, 8390, and 8730

On July 21, CMS published One-Time Notification Transmittal 10896which rescinds and replaces Transmittal 10801, dated May 20, 2021, to add business requirements 12282.13, 12282.14, 12282.15, 12282.16, and 12282.17. The original transmittal was published regarding the addition of HCPCS codes which require the use of a licensed/certified orthotist or prosthetist for furnishing orthotics or prosthetics under two additional product and service codes: OR01 (orthoses: custom fabricated) and OR02 (prefabricated [custom fitted]).

Effective date: October 1, 2021

Implementation date: October 4, 2021


CY 2021 APM Incentive Payment Advisory for Clinicians

On July 22, CMS published a Payment Advisory in the Federal Register to alert clinicians who are qualifying APM participants and eligible to receive an APM incentive payment that CMS doesn’t have the billing information needed for payment. The advisory instructs clinicians on how to update their billing information to receive payment. 

Dates: Updated billing information is due no later than November 1, 2021.