This week in Medicare updates—6/29/2022
COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers
On June 16, CMS revised a Fact Sheet regarding the blanket waivers issued during the COVID-19 PHE. The revision note which waivers were terminated in recent months and discuss deadlines for completing certain tasks now that applicable waivers were terminated.
CY 2023 Home Health Prospective Payment System (HH PPS) Proposed Rule
On June 17, CMS published a draft version of the CY 2023 HH PPS Proposed Rule, which was published in the Federal Register on June 23. The rule proposes a -7.69% permanent adjustment to the 30-day payment rate in CY 2023 to ensure that aggregate expenditures under the new Patient-Driven Groupings Model would be equal to what they would have been under the old payment system. It is also seeking comments on how to implement a temporary payment adjustment in the future to correct for $2 billion in excess estimates for 2020 and 2021. The rule proposes a permanent 5% cap on negative wage index changes and proposes recalibrating case-mix weights and LUPA thresholds using CY 2021 data.
CMS estimates that the aggregate home health payment update will be -4.2% for CY 2023 due in large part to an estimated 6.9% decrease from the effects of the proposed prospective permanent behavioral health assumption adjustment of 7.69%.
CMS published a Fact Sheet on the rule on the same date. Comments are due by August 16.
ICD-10 and Other Coding Revisions to NCDs–October 2022 Update
On June 17, CMS published One-Time Notification Transmittal 11460, which rescinds and replaces Transmittal 11400, dated May 4, to update NCD 90.2, NGS, spreadsheet to conform with changes in CY 12124 and change the implementation date for all business requirements except 12705.6 to 30 days from issuance of this correction. The original transmittal was published regarding the maintenance update of ICD-10 conversions and other coding updates specific to NCDs.
On June 22, CMS revised MLN Matters 12705 on the same date to accompany the transmittal.
Effective date: October 1, 2022 - or as indicated in individual business requirements
Implementation date: July 19, 2022 - A/B MACs, for all business requirements except 12705.6; October 3, 2022 - SSMs, business requirement 12705.6 only
CY 2023 End Stage Renal Disease Prospective Payment System Proposed Rule
On June 21, CMS published a draft copy of the 2023 ESRD PPS Proposed Rule, which is scheduled to be published in the Federal Register on June 28. Proposals include a change to the methodology for calculating outlier threshold for adult patients, rebasing and revising of the ESRD Bundled market basket, and a permanent 5% cap on decreases in the ESRD PPS wage index beginning in CY 2023. CMS also proposed changing the definition of “oral-only drug” to include wording stating that it’s a drug or biological product with no injectable functional equivalent or other form of administration, and it proposed clarifying the descriptions of the ESRD PPS functional categories to help ensure CMS supports innovation of completely new drugs and not variations of existing drugs.
CMS estimates payment updates in the rule will increase ESRD payments for freestanding clinics by 3.1% and increase payments for hospitals by 3.7%. The proposed CY 2023 ESRD PPS base rate is $264.09.
CMS published a Fact Sheet on the proposed rule on the same date. Comments are due by August 22.
Updated Civil Monetary Penalties and Affirmative Exclusions
On June 21, the OIG published an updated List of Civil Monetary Penalties and Affirmative Exclusions, including:
- On June 1, West Bay Residential Services, of Warwick, RI, reached a $325,910 settlement with the OIG to resolve allegations that it employed individuals who were excluded from participation in federal health care programs.
- On June 10, Melissa Robitaille, DPM, and Atlantic Foot and Ankle Specialists, of Richmond Hill, Georgia, were excluded for defaulting on payment obligations under a settlement agreement with the Department of Justice and the OIG.
- On June 10, Maria McIntire, MD, of Illinois, reached $162,690 settlement agreement with the OIG to resolve allegations that she received remuneration from telemedicine companies in exchange for ordering durable medical equipment paid for by Medicare.
- On June 10, Elizabeth Snoderly, DO, of Myrtle Beach, South Carolina, reached a $297,130.76 settlement agreement with the OIG to resolve allegations that she submitted claims to Medicare for facet joint injection and denervations in excess of the allowable number of sessions in a 12-month period.
NCD 90.2, Next Generation Sequencing (NGS)
On June 21, CMS published One-Time Notification Transmittal 11461, which rescinds and replaces Transmittal 11055, dated October 21, 2021, to revise BR 12483.1 and the corresponding spreadsheet to align with changes made in previous CR 12124 and later CR 12705. The original transmittal was published regarding updates to ICD-10 diagnosis codes for clinical diagnostic lab tests related to the NGS policy.
Effective date: July 1, 2020
Implementation date: November 23, 2021
Updated Corporate Integrity Agreement Documents
On June 22, the OIG published information on new Corporate Integrity Agreements with the following entities:
- SNAP Diagnostics, LLC and Gil Raviv, of Wheeling, IL
- Steward Good Samaritan Medical Center, of Westwood, MA
Comment Request: Medical Loss Ratio Annual Reports, MLR Notices, and Recordkeeping Requirements
On June 22, CMS published a Comment Request in the Federal Register regarding the following information collection:
- Medical Loss Ratio Annual Reports, MLR Notices, and Recordkeeping Requirements
Comments are due by August 22.
Comment Request: Hospital and Health Care Complex Cost Report; more
On June 22, CMS published a Comment Request in the Federal Register regarding the submission of the following information collections for OMB review:
- Hospital and Health Care Complex Cost Report
- Blueprint for Approval of State-based Exchange
Comments are due to the OMB desk officer by July 22.
July 2022 Update of the Ambulatory Surgical Center (ASC) Payment System
On June 23, CMS published Medicare Claims Processing Transmittal 11472, which rescinds and replaces Transmittal 11452, dated June 9, to update Attachment A, table 3 to remove HCPCS A9601 and J0739. CMS is also correcting the number of new drug codes in section 3A of the business requirement’s policy section from 16 to 14.
CMS revised MLN Matters 12773 on the same date to accompany the transmittal.
Effective date: July 1, 2022
Implementation date: July 5, 2022
Federal Payment Tax Levy
On June 23, CMS published Medicare Financial Management Transmittal 11462 regarding information for contractors on how to handle tax levies for Medicare payments to providers and suppliers according to the Federal Payment Levy Program.
Effective date: July 25, 2022
Implementation date: July 25, 2022
Changes to the Laboratory National Coverage Determination (NCD) Edit Software for October 2022
On June 23, CMS published Medicare Claims Processing Transmittal 11465 regarding changes to the laboratory NCD edit module for October 2022. There are 12 NCDs affected by coding updates in October.
CMS revised MLN Matters 12803 on the same date to accompany the transmittal.
Effective date: October 1, 2022
Implementation date: October 3, 2022
Claims Processing Manual Update, Chapter 16, Section 70.5, 70.8, and 70.9 to Remove References to the CLIA Files
On June 23, CMS published Medicare Claims Processing Transmittal 11463 regarding updates to the manual to remove references to CLIA files. Information on CLIA test complexity categorization can be found on the FDA website.
Effective date: July 25, 2022
Implementation date: July 25, 2022
Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 28.3, Effective October 1, 2022
On June 23, CMS published Medicare Claims Processing Transmittal 11471 regarding the quarterly updates to the NCCI PTP edits. The file containing these edits should be available on or about August 17.
Effective date: October 1, 2022
Implementation date: October 3, 2022
Advisory Opinion No. 22-13
On June 23, the OIG published an Advisory Opinion regarding whether the OIG would impose sanctions under the federal anti-kickback statute based on an arrangement in which a durable medical equipment manufacturer entered into agreements with two third-party financial institutions to make zero-interest financing available to customers. These options are intended to enable smaller DME suppliers to compete with larger, corporate DME suppliers by enabling them to purchase and dispense DME that might be subject to a lengthy reimbursement timeline.
The OIG determined that while this arrangement implicates the anti-kickback statute, 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, such as the lack of any discount or other price concession, the involvement of risk-bearing lenders, the lenders’ lack of involvement in federal health care programs, and more as discussed in depth in the Opinion.
Updated EUA for Pfizer, Moderna Vaccines
On June 24, 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 June 17 to authorize use for patients 6 months and older.
CMS added information about payment rates for the new pediatric doses to its Medicare COVID-19 Vaccine Shot Payment page. Payment remains the same ($40 per dose) for the expanded pediatric doses as it does for other doses.