This week in Medicare updates—9/21/2022

September 20, 2022
Medicare Insider

Updated EUA for Pfizer, Moderna Vaccines

On September 12, CMS updated its COVID-19 Toolkit to note that the FDA revised the Emergency Use Authorization (EUA) for the Pfizer and Moderna COVID-19 vaccine on August 31 to authorize use for the bivalent formulations of the vaccines as a booster dose. CMS noted that patients may refer to this as the “updated COVID-19 vaccines.”

CMS added information about coding for the bivalent vaccines to its COVID-19 Vaccines and Monoclonal Antibodies page. Payment remains the same ($40 per dose) for the bivalent doses as it does for other doses. CMS published a News Alert about the bivalent doses on the same date.


Analysis of Coverage with Evidence Development Criteria

On September 12, CMS published an Announcement saying it will convene the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to examine the requirements for clinical studies submitted for CMS coverage under Coverage with Evidence Development (CED). CMS noted that it has been almost eight years since it last evaluated and codified criteria for CED. 

The meeting will be held on December 7.


Medicare Advantage Compliance Audit of Specific Diagnosis Codes that Regence Blue Cross Blue Shield of Oregon Submitted to CMS

On September 13, the OIG published a Review of whether select diagnosis codes that Regence Blue Cross Blue Shield of Oregon submitted to CMS for use in the risk adjustment program complied with federal requirements. The OIG conducted the audit by sampling 179 unique enrollee-years with high-risk diagnosis codes for which Regence received higher payments for 2015 and 2016. The OIG found that diagnosis codes for 111 of the 179 enrollee-years did not comply with federal requirements because there was not sufficient support for those codes in the medical records. The OIG estimated that based on the results of the sample, Regence received at least $1.8 million in net overpayments in 2015 and 2016.

The OIG recommended that Regence refund the federal government for the $1.8 million in net overpayments, identify and return similar overpayments, and continue its examination of its policies and procedures to identify areas where improvements can be made to ensure diagnosis codes at high risk for being miscoded comply with federal requirements. Regence disagreed with the OIG’s findings and recommendations, but the OIG maintained that its findings and recommendations were correct.


Annual Clotting Factor Furnishing Fee Update 2023

On September 13, CMS published Medicare Claims Processing Transmittal 11596, which rescinds and replaces Transmittal 11567, dated August 18, to remove the Durable Medical Equipment MACs from business requirement 12860.2. The original transmittal was published regarding the annual update to the clotting factor furnishing fee, which will be $0.250 per unit in 2023.

Effective date: January 1, 2023

Implementation date: January 3, 2023


Updated OIG Work Plan

On September 15, the OIG updated its Work Plan with the following new items:


Opioid Overdoses and the Limited Treatment of Opioid Use Disorder Continue to be Concerns for Medicare Beneficiaries

On September 15, the OIG published a Data Brief regarding opioid use, access to treatment for beneficiaries with opioid use disorder, and access to naloxone among Medicare Part D beneficiaries in 2021. The OIG found that about 50,400 Part D beneficiaries experienced an opioid overdose in 2021, but that number is likely higher because it does not account for any beneficiaries who overdosed but did not receive medical care that was billed to Medicare. The number of prescribers ordering opioids for large numbers of beneficiaries at serious risk stayed steady with previous years, and over one million Medicare beneficiaries had a diagnosis of opioid use disorder in 2021. Fewer than 1 in 5 of the one million Medicare beneficiaries with that diagnosis received medication to treat their disorder. 

In positive trends, the number of Part D beneficiaries who received opioids in 2021 decreased to almost a quarter of beneficiaries, and fewer Part D beneficiaries were identified as receiving high amounts of opioids or at serious risk than in previous years. The number of Part D beneficiaries receiving naloxone increased from previous years.


Comment Request: Financial Statement of Debtor; more

On September 15, CMS published a Comment Request in the Federal Register regarding the following information collections:

  • Financial Statement of Debtor
  • Elimination of Cost-Sharing for Full Benefit Dual-Eligible Individuals Receiving Home and Community-Based Services
  • Provider Network Coverage Data Collection
  • Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
  • Social Security Office (SSO) Report of State Buy-In Problem

Comments are due by November 14.


Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 29.0, Effective January 1, 2023

On September 15, CMS published Medicare Claims Processing Transmittal 11599 regarding a reminder that the quarterly update for the NCCI PTP edits will be available via the CMS Virtual Data Center on or about November 17, 2022.

Effective date: January 1, 2023

Implementation date: January 3, 2023


Annual Update of the HCPCS Codes Used for Home Health Consolidated Billing Enforcement

On September 15, CMS published Medicare Claims Processing Transmittal 11601 to provide the January 2023 update to the list of HCPCS codes used to enforce consolidated billing of home health services.

Effective date: January 1, 2023

Implementation date: January 3, 2023