This week in Medicare updates—9/7/2022

September 7, 2022
Medicare Insider

Final Rule: Radiation Oncology (RO) Model Delay

On August 29, CMS published a Final Rule in the Federal Register to delay the start of the RO Model to a date to be determined through future rulemaking and to modify the definition of the model performance period so that the start and end dates will be decided by future rulemaking. Although CMS said it continues to believe that the RO Model would address long-standing concerns related to these services, it noted that the RO Model has now been delayed by Congress twice and the concern about the resources involved in preparing to implement the model as well as comments received by stakeholders throughout this process necessitate an indefinite delay to the model. 

These regulations are effective on October 28, 2022.


Comment Period Extension for CLIA Fees: Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories

On August 29, CMS published a Notice in the Federal Register regarding the extension of the comment period for a proposed rule regarding updates to CLIA fees and clarification of certain CLIA regulations. The rule was initially published in the Federal Register on July 26, and CMS is extending the comment period by an additional 30 days due to requests from several laboratory professional organizations. 

Dates: The comment period for the proposed rule published July 26, 2022 (87 FR 44896) is extended through September 26, 2022.


Update to COVID-19 Emergency Declaration Blanket Waivers for Specific Providers

On August 29, CMS revised a Memorandum to state survey agency directors regarding the end of certain COVID-19 emergency declaration blanket waivers for certain provider types to provide more information related to waivers of the Nurse Aide Training Competency and Evaluation requirements. The additions include information on how CMS will review individual facility waivers as well as state-wide or county waivers. 

Effective date: The emergency declaration blanket waivers identified in the memo will end according to the timeframes discussed within the memo.


Medicare Shared Savings Program Saves Medicare More Than $1.6 Billion in 2021 

On August 30, CMS published a Press Release regarding the Medicare Shared Savings Program (MSSP), which CMS said saved Medicare $1.66 billion in 2021 compared to spending targets. CMS reiterated its goal to have 100% of people with traditional Medicare participating in an accountable care relationship by 2040. The 2023 Physician Fee Schedule Proposed Rule also included proposals to promote participation in the MSSP among health care providers in rural and underserved communities.


Medicare Advantage Compliance Audit of Specific Diagnosis Codes that WellCare of Florida Submitted to CMS

On August 30, the OIG published a Review of whether select diagnosis codes that WellCare of Florida submitted to CMS for use in the risk adjustment program complied with federal requirements. The OIG conducted the audit by sampling 250 unique enrollee-years with high-risk diagnosis codes for which WellCare received higher payments for 2015 through 2016. The OIG found that diagnosis codes for 153 of the 250 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, WellCare received at least $3.5 million in net overpayments in 2015 and 2016.

The OIG recommended that WellCare refund the federal government for the $3.5 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. WellCare disagreed with some of the findings, the audit methodology, and the expectation that it should ensure that 100% of diagnosis codes received from providers and submitted to CMS are accurate. The OIG revised the number of enrollee-years in error from 156 in the draft report down to 153 in this final report.


Increased Use of Telehealth for Opioid Use Disorder Services During COVID-19 Pandemic Associated with Reduced Risk of Overdose

On August 31, CMS published a Press Release regarding a new study published in JAMA Psychiatry which analyzed the use of telehealth services, medications for opioid use disorder, and treating overdoses in individuals with opioid use disorder prior to the pandemic as compared to those during the pandemic. The study showed that beneficiaries were more likely to receive opioid use disorder-related telehealth services during the pandemic and the use of those services was associated with significantly better medication utilization retention and a lower risk of overdose. CMS said this data adds to evidence showing that access to these services could have a longer-term positive impact if they continue beyond the pandemic.


FDA Amends EUA for Novavax COVID-19 Vaccine

On August 31, CMS updated the COVID-19 Vaccine and Monoclonal Antibody webpage regarding the Novavax COVID-19 vaccine. The FDA revised the EUA for the vaccine on August 19 to approve the use of the vaccine in patients aged 12-17 years old. Providers should use the same codes for the pediatric doses as they use for the adult doses and administration. As with other vaccines, payment rates for each dose will be $40.


Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2023

On September 1, CMS published Medicare Claims Processing Transmittal 11583 regarding the January 2023 quarterly update to the edit module for clinical diagnostic laboratory services.

Effective date: January 1, 2023 - Unless noted differently in requirements

Implementation date: January 3, 2023


Artificial Hearts and Related Devices - Retired

On September 1, CMS published a Notice regarding NCD 20.9 (Artificial Hearts and Related Devices) to note that effective December 1, 2020, this section has been removed from the NCD Manual as coverage of artificial hearts and related devices are now being made by the MACs. 

This change was implemented via Medicare National Coverage Determinations Transmittal 10837, which was published June 11, 2021.