Enhancing Oncology Model – Industry News, June 2022

New Model for Cancer Care Announced

On June 27, 2022, a new voluntary model was announced to improve cancer care for Medicare beneficiaries.

The Centers for Medicare and Medicaid Services’ (CMS) Center for Medicare and Medicaid Innovation Center announced the newly designed Enhancing Oncology Model (EOM). CMS cites the central goal of the EOM is to better support patients and improve their care experience by implementing the following key elements:

• CMS will give participants the option to bill for a Monthly Enhanced Oncology Services (MEOS) payment for Enhanced Services provided to eligible beneficiaries. The MEOS payment will be higher for beneficiaries dually eligible for Medicare and Medicaid.
• EOM participants will have the opportunity to earn a retrospective performance-based payment (PBP) based on quality and savings. Participants will be required to take on downside risk from the start of the model (with the potential to owe CMS a performance-based recoupment).
• EOM participants will be required to implement participant redesign activities, including 24/7 access to care, patient navigation, care planning, use of evidence-based guidelines, use of electronic Patient Reported Outcomes (ePROs), screening for health-related social needs, use of data for quality improvement, and use of certified electronic health record technology.
• EOM will focus on beneficiaries receiving systemic chemotherapy (that is, not beneficiaries receiving hormonal therapy only) for seven cancer types: breast cancer, chronic leukemia, small intestine/colorectal cancer, lung cancer, lymphoma, multiple myeloma, and prostate cancer.

The multi-payer model participation will be on the national level for those who apply to participate. There will be two parts of the EOM; one operated by CMS for Medicare fee-for-service (FFS), and another operated by EOM payers for their enrollees who are patients of an EOM participant.

The application submission period to opt-in to the model opened June 27, 2022, and will close September 30, 2022. The model performance period is slated to being July 2023 and end in June 2028.

MAC Probe Results Provide Denial Insights

Medicare Administrative Contractors (MACs) have released their findings from a multitude of probes spanning both radiation and medical oncology. A review of their findings and subsequent recommendations to avoid denials is recommended.

Palmetto GBA released pre-payment probe results for both Intensity Modulated Radiotherapy (IMRT) planning as well MLC Device(s) for IMRT, CPT® codes 77301 and 77338, respectively. The provider-specific claims analysis for IMRT treatment planning, code 77301, resulted in a 67 percent claims denial with a 13 percent charge denial rate. IMRT MLC Device(s), code 77338, resulted in an overall denial rate of 72 percent with a charge denial rate of 4 percent. The primary denial reason provided for those claims which were either completely or partially denied, for BOTH 77301 and 77338 is listed as “No Documentation of Medical Necessity.”

Palmetto GBA also released provider-specific pre-payment probe results for Denosumab (Prolia®) for September 2021 through March 2022 in North and South Carolina, Virginia and West Virginia. The result of the probe showed an overall claim denial rate of seven percent for code J0897 (injection, denosumab, 1 mg) totaling a 17 percent charge denial of $20,535.83. The top denial reason, based on dollar amount was “No Documentation of Medical Necessity” followed by “The Recommended Protocol Was Not Ordered and/or Followed.”

Separately, First Coast Service Options identified Prolia® injections (J0897) as a top claim denial during 2021. The top claim error was the billing of incorrect units. First Coast has released an information on the appropriate billing for Prolia® injections.

U.S. Supreme Court Rules 340B Cuts Unlawful

In a unanimous decision, on June 15, 2022, the U.S. Supreme Court (SCOTUS) ruled to overturn a 2020 decision which allowed the Department of Health and Human Services (HHS) to reduce payments to certain participants of the 340B drug pricing program.

The ruling in favor of hospitals states the roughly 30 percent reduction in Medicare reimbursement implemented in 2018 and 2019 for outpatient drug payments for 340B participating hospitals were against the law.

The ruling states HHS does not have the authority to reduce reimbursement for 340B hospitals without first conducting a survey of the hospital’s drug acquisition costs, which they did not do in 2018 or 2019.

In a joint statement, the American Hospital Association (AHA), the Association of American Medical Colleges (AAMC), and America’s Essential Hospitals said the following about the decision:

“This decision is a decisive victory for vulnerable communities and the hospitals on which so many patients depend… We look forward to working with the Administration and the courts to develop a plan to reimburse 340B hospitals affected by these unlawful cuts while ensuring the remainder of the hospital field is not disadvantaged as they also continue to serve their communities.”

First Price Transparency Penalties Handed Down

The Centers for Medicare and Medicaid Services (CMS) has announced the first monetary penalties have been issued under the Hospital Price Transparency Rule to two hospitals for failure to make public a list of standard charges.

Effective January 1, 2021, the price transparency rule requires hospitals to make their negotiated rates for at least 300 standard services public and easily accessible. The rule requires hospitals to also make public their self-pay and charge master rates as well as provide an online patient cost estimator tool. Up until their recent announcement, CMS had only issued warning letters to non-compliant hospitals, but no monetary fines had been issued. The rule outlines failure to comply to the price transparency rule could result in fines from $300 to $5,500 per day, dependent on the hospital’s size. A recent JAMA analysis indicated 6 to 9 months after the final rule went into effect there was roughly a 51% of non-compliance to the final rule. CMS has published their enforcement actions with a list of civil monetary penalty (CMP) notices on their Hospital Price Transparency website.

Noridian Makes Revisions to PET Coverage Policy

Effective February 18, 2022, CMS has published updates to its National Coverage Determination (NCD) for Positron Emission Tomography (PET) scans. Noridian, the Medicare Administrative Contractor (MAC) for Alaska, Idaho, Oregon, Washington, Arizona, Montana, the Dakotas, Utah, and Wyoming, recently made some updates to their policy to reflect changes that have occurred in related policies and documents.

Updates to Noridian’s LCD A54668, related to NCD 220.6.17, include a corrected link referencing CMS CR12613 and revision of its effective date to May 20, 2022, under Sources, as well as clarification stating ICD-10 code Z85.3 must be billed with either any of the C50.XXX codes or C79.81, and adding breast cancer codes (C50.XXX) to the ICD-10-CM Codes that Support Medical Necessity in the Group 14 paragraph.

The following statement was removed from the Groups 11 and 13 paragraphs in the NCD:

“Effective 09/10/2021, the NCCN Guidelines have been updated to allow PET/CT or PET/MRI with Fluciclovine F18 to be considered for equivocal results on initial bone imaging with the ‘PI’ modifier” and “Effective 09/10/2021, the NCCN Guidelines have been updated to allow PET/CT or PET/MRI with Fluciclovine F18 to be considered for equivocal results on initial bone imaging with the use of the ‘PI’ modifier” as the use of the ‘PI’ continues to be nationally non-covered per NCD 220.6.17 C.1a.”

The following statement was added to the policy in the Group 1, 17 and 19 paragraphs:

“Providers must amend the KX modifier on the claim to attest that the use of the PI modifier is per NCCN Guidelines” and the approved FDA label indications for each tracer.”

Finally, HCPCS code A9597 was added to the Group 20 paragraph for LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection) as payable with 78811-78816 and the ‘PI’ or ‘PS’ modifier, the approved FDA label indications for the tracer and added the statement “Providers must amend the KX modifier on the claim to attest that the use of the PI modifier is per NCCN Guidelines.” Additionally, the following diagnosis codes were added to the Group 20 Codes section:

C61 – Malignant neoplasm of prostate
R97.21 – Rising PSA following treatment for malignant neoplasm of prostate
Z85.46 – Personal history of malignant neoplasm of prostate

To view the NCD in its entirety, please click here.

CMS Issues July 2022 ASC Payment Update

On June 9, The Centers for Medicare and Medicaid Services (CMS) released the July 2022 Update of the Ambulatory Surgical Center (ASC) Payment System. The effective date for this change request (CR12773) is July 1, 2022, and an implementation date of July 5, 2022.

The update provides information on the new Category III CPT® code 0714T (Transperineal laser ablation of benign prostatic hyperplasia, including imaging guidance). Additionally, 16 new drug and biological HCPCS codes will go into effect July 1, 2022, with the previous codes deleted June 30, 2022.

CY 2023 ESRD Proposed Rule Released

On June 21, 2022, the Centers for Medicare and Medicaid Services (CMS) issued the calendar year (CY) 2023 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule for renal dialysis services furnished to Medicare beneficiaries.

Some key proposals, as outlined in CMS’ summary of proposed changes include:

• Rebase and revise ESRD Bundled market basket
• Modify ESRD PPS methodology for calculating outlier thresholds
• Permanent 5% cap on decreases in ESRD PPS wage index
• Change “oral-only drug” definition
• Update requirements for ESRD Quality Incentive Program
• Proposals for Payment Years 2024, 2025 and 2026

Comments can be submitted electronically by August 22, 2022.

ICD-10-CM Updates Released for FY 2023

The Centers for Medicare and Medicaid Services (CMS) has released ICD-10-CM diagnosis code updates and guideline changes for FY 2023. These updates and codes go into effect on October 1,2022.

Of particular note, the ICD-10-CM guidelines have been updated to include references to codes for underimmunization status (Z28.3x, new for 2022), as well as clarification on code assignment for complications of care. Updated language was also added to clarify coding for neoplasms for admission/encounter for treatment of a primary site or secondary site, as well as secondary malignant neoplasm of lymphoid tissue. Additional updates were made to the diabetes mellitus section of the guidelines to provide guidance for new code Z79.85, Long-term (current) use of injectable non-insulin antidiabetic drugs.

Several significant changes were made to the dementia section of the coding guidelines as well as the dementia codes themselves (categories F01, F02, and F03).

Other revised and added codes for FY 2023 include (but are not limited to) codes for hemolytic-uremic syndrome (D59.3x), Von Willebrand disease (D68.0x), heparin induced thrombocytopenia (HIT) (D75.82x), ischemic heart diseases/angina pectoris (I20-I25), dissection of aorta (I71.0x), endometriosis (N80.x), and long term (current) use of chemotherapeutic agent (Z79.63x).

To view the updates in their entirety, please click here.