Industry News, July 2023

ASTRO’s Legislative Proposal

On June 23, 2023, the American Society for Radiation Oncology (ASTRO) released a Radiation Oncology Payment Reform Legislative Proposal, Radiation Oncology Case Rate (ROCR).

​Per ASTRO, ROCR would:

• Change radiation oncology payment from per fraction to per patient.
• Reverse decade-long declines in Medicare payments.
• Usher in a new era of stable payments, higher quality care and reduced disparities.

ASTRO Legislative Proposal

The Radiation Oncology Alternative Payment Model (RO APM or RO Model) was delayed indefinitely by the Centers for Medicare and Medicaid Services (CMS) on August 29, 2022. The baseline for ROCR is similar to and modeled after the CMS RO Model. There are many shared qualities between them, but also some distinct differences proposed by ASTRO. Base rates for the ASTRO proposal are calculated using the CMS base rates last modified by CMS in CY 2022 and assigned to the M-codes for reporting. ASTRO intends all radiation oncology practices participating in Medicare to participate in ROCR instead of a predetermined selection of practices as outlined in the RO Model. ASTRO projects the ROCR program will save CMS approximately $212 million from 2024-2028 compared to same services under fee-for-service payments under MPFS. 
​
This proposal will be sent to Congress for consideration, but ASTRO’s Health Policy team is seeking feedback before submitting. There are several items available on the ASTRO website for additional review and more in-depth explanation of the proposed payment reform.
Resources

• Policy Paper
• Technical Document
• ROCR Pricing Model Professional and Technical Component
• ROCR Feedback Form​

​

CY 2024 Proposed Rules Released

On July 13, 2023, the Centers for Medicare and Medicaid Services (CMS) issued the proposed rules for the Hospital Outpatient Prospective Payment System (HOPPS) and Medicare Physician Fee Schedule (MPFS) for CY 2024. The following is a high-level overview of the proposed rules, it is recommended to review the rules in their entirety for further details.

HOPPS

The CY 2024 proposed rule is 963 pages in length. The below are highlights from the HOPPS proposed rules.

• $87.488 conversion factor (CF) for hospitals that meet the Hospital OQR reporting requirements.
• $85.782 CF for hospitals that do not meet the Hospital OQR reporting requirements.
• 340B Drug Discount Program rates = average sale price (ASP) +6 percent
  • Simplify reporting process by only using “TB” modifier (cease using “JG” modifier) to identify 340B acquired drugs and biologicals.
• Wage index
  • Frontier states = 1.0000
  • Apply a 5 percent cap on any decreases to hospital’s wage index from previous year’s wage index.
  • Utilize IPPS post-reclassification wage index for urban and rural areas as the wage index for HOPPS to determine the wage adjustments for both the HOPPS payment rate, and the copayment rate.
• Continue additional payments to cancer hospitals utilizing a payment-to-cost ration (PCR) factor
  • Target PCR of 0.88 to determine payment adjustment to be paid at cost report settlement.
• Continue to use G0463 as the standardized code for the relative payment weights
  • Continue to pay G0463 at 40 percent of HOPPS rate for any outpatient off-campus hospital setting, excepted and nonexcepted
• Continuation of special payment policy and methodology for the HOPPS complexity-adjusted comprehensive ambulatory payment classifications (C-APCs).
• Procedures assigned to new technology APC groups
  • LiverMultiScan, Optellum LPC, Quantitative Magnetic Resonance Cholangiopancreatography (QMRCP), Scalp Cooling
• Due to insufficient and/or unreliable claims data since 2018, CMS proposed to use their equitable adjustment authority to maintain the CY 2023 rate of $4.69 per mm2 for HCPCS code C2645 (Brachytherapy planar source, palladium-103, per square millimeter)
• End pass-through payments for 25 drugs and biologicals, continue pass-through payment status for 42 drugs and biologicals
  • Package drugs and biologicals estimated at a per day administration cost less than or equal to $140 (CY 2023 was set at less than or equal to $135)
• Amend the hospital price transparency (HPT) requirements
  • Revised standard charge information and data elements which must be included; require hospitals to use a CMS developed template
  • Improve accessibility by requiring hospitals to include a direct link to publicly available webpage with the required machine-readable file (MRF)
  • Improve enforcement process
• Implement the Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography (CT) in Adults electronic clinical quality measure (the Excessive Radiation eCQM)

Comments to CMS regarding the HOPPS proposed rule must refer to file code CMS-1768-P and be received no later than 5 pm EST September 11, 2023.  Electronic and mail submissions are acceptable, electronic submissions are encouraged: Visit regulations page. Follow the instructions under the “submit a comment” tab.

MPFS

The CY 2024 proposed rule is 2,033 pages in length.
CMS is proposing:

• Conversion factor (CF) = 32.7476, a decrease from CY 2023 CF of 33.8872
• Proposed misvalued or value changes to specific codes and code sets:

• Dorsal Sacroiliac Joint Arthrodesis

(CPT® code 2X000)

• Vertebral Body Tethering

(CPT® codes 2X002, 2X003, 2X004)

• Total Disc Arthroplasty

(CPT® codes 22857 and 22860)

• Transcervical RF Ablation of the Uterine Fibroids (CPT® code 5X005)
• Spinal Neurostimulator Services

(CPT® codes 63685, 63688, 64XX2, 64XX3 and 64XX4)

• Ultrasound Guidance for Vascular Access

(CPT® code 76937)

• Neuromuscular Ultrasound

 (CPT® codes 76881, 76882, 76883)

• General Behavioral Health Integration Care Management

(CPT® code 99484 and HCPCS code G0323)

• Advanced Care Planning

(CPT® codes 99497 and 99498)

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (CPT® codes 9X034 and 9X035)

• Change the status indicator of G2211 from “B” (bundled) to “A” (active); would not be payable when the O/O E/M visit code is reported with payment modifier 25 due to performance with a minor procedure
• Delay the implementation of updated definition of “substantiative portion” for split (or shared) visits 
• Remote therapy monitoring (RTM) and remote physiologic monitoring (RPM) clarifications
• Continuation of payment for audio-only E/M codes 98966-98968, similar to other audio-only codes.
• Except biosimilars from the threshold packaging policy when their reference biologicals are separately paid; if a reference product’s per-day cost falls below the threshold packaging policy, all the biosimilars related to the reference product would be similarly packaged regardless of whether their per-day costs are above the threshold
• CMS is seeking comments on whether they should revise policy guidelines to better reflect how specific infusion services are furnished and should be billed.
• CMS is proposing several new provisions and modification to the manufacturer refund policy for CY 2024.
• Extend the definition that allowance for direct supervision to be met with the use of real-time audio and video interactive telecommunications through December 31, 2024.
• Proposing to allow the teaching physician to have a virtual presence in all teaching settings, but only in clinical instances when the service is furnished virtually (3-way telehealth visit, with all parties in separate locations)
• To create new coding to identify and value social determinants of health (SDOH), Community Health Integration (CHI) Services, Principal Illness Navigation (PIN) Services for PFS payment and distinguish them from current care services.
• Pause AUC implementation and rescind current regulations

Comments to CMS regarding the MPFS proposed rule must refer to file code CMS-1784-P and be received no later than 5 pm EST September 11, 2023. Electronic and mail submissions are acceptable, electronic submissions are encouraged. Follow the instructions under the “submit a comment” tab.     ​

CMS TCET Proposed Rule

On June 27, 2023, the Centers for Medicare and Medicaid Services (CMS) issued the proposed rule for the   Medicare Program; Transitional Coverage for Emerging Technologies (TCET).
CMS is proposing to provide transitional coverage for emerging technologies (TCET) through the national coverage determination (NCD) process. This pathway is intended to provide more transparency, predictability, and expedited national coverage for eligible Breakthrough Devices, authorized by the Food and Drug Administration (FDA); and continue through procedural notice rather than rulemaking process as another way to expedite the process.

Currently the Medicare beneficiaries who may be looking for emerging technologies which have limited evidence, can participate in Coverage with Evidence Development (CED), in approved clinical studies. CMS believes this proposal will improve the current process of CED and the work they do in conjunction with the Agency for Healthcare Research and Quality (AHRQ), by making better, informed decisions about the potential health outcomes and ensure beneficiaries have equitable access to care as other parts of population.

The TECT pathway proposal is intended to assist CMS when making coverage decisions through the following considerations:

• Facilitate early, predictable and safe beneficiary access to new technologies;
• Reduce uncertainty regarding coverage by early evaluation of the potential benefits and harms of technologies with innovators; and
• Encourage evidence development if notable evidence gaps exist for coverage purposes.

In addition, the TCET pathway aims to coordinate benefit category determination, coding, and payment reviews and to allow any evidence gaps to be addressed through fit-for-purpose studies.

The Breakthrough Devices Program will have 2 levels of criterion that must be met in order to be eligible for the TCET pathway. CMS describes them as follows:

• The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
• The device must satisfy one of the following elements:
  1. It represents a breakthrough technology;
  2. No approved or cleared alternatives exist;
  3. It offers significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies;
  4. Device availability is in the best interest of patients.

There are 3 stages of the TCET pathway proposed: 1) premarket, 2) coverage under TCET pathway, and 3) transition to post-TCET coverage. TCET pathway limits who may be eligible, and CMS indicated there are other expedited options for coverage that may be available to those who do not qualify, namely a Parallel Review, will continue to be an option.  CMS will work with the FDA to discuss potential updates to the current Parallel Review process between the two entities for greater efficiency and simplicity of coverage considerations for non-Breakthrough Devices.

Submitting Comments
Comments to CMS regarding the Medicare TCET must refer to file code CMS-3421-N and be received no later than 5 pm EST August 28, 2023.  Electronic submission is encouraged by CMS. Visit regulations page to submit a comment. Follow the instructions under the “submit a comment” tab.

CMS Proposes Expanded PET Coverage

The Centers for Medicare and Medicaid Services (CMS) has proposed to expand coverage of amyloid-detecting positron emission tomography (PET) scans related to Alzheimer’s disease.

CMS’ proposed decision is to remove the national coverage determination (NCD) which outlines the restricted allowance of one amyloid-detecting PET exam in a lifetime. CMS is proposing to permit local Medicare Administrative Contractors (MACs) to make the payment determination.

Recently, the U.S. Food and Drug Administration (FDA) approved Leqembi (lecanemab-irmb), indicated in the treatment of Alzheimer’s. Leqembi works by targeting and eliminating the protein that builds up in the brains of individuals with Alzheimer’s. Beta-amyloid PET imaging is required to establish patients who are candidates for the treatment.
The proposed decision was posted July 17, 2023. There is a 30-day public comment period window.