CMS’ Plan To End of the PHE – Industry News, August 2022

CMS’ Roadmap for the End of the PHE

On August 18, The Centers for Medicare and Medicaid Services (CMS) released their plan and corresponding information to assist providers in preparing for the eventual termination of waivers and flexibilities that will come with the end of the COVID-19 public health emergency (PHE).

While HHS Secretary Becerra has committed to providing 60 days’ notice before ending the PHE, CMS is encouraging healthcare providers to prepare for the end of the PHE waivers and flexibilities and returning to previous health and safety standards and billing practices as soon as possible to avoid disruptions and potential coverage losses. In order to assist healthcare providers, facilities, insurers and other stakeholders to prepare for the end of the PHE waivers and flexibilities, CMS has issued a Health Care System Resiliency plan along with providing guidance to states for the transition process.

While some waivers and flexibilities are slated to end 151 days after the conclusion of the PHE, CMS has stated that unless otherwise specified within their fact sheets, the list of COVID-19 waivers will end with the PHE.

RO Model Update

Final Rule Released 8.25.22


October HCPCS Update Includes New Codes for PET Radiopharmaceuticals, Cancer Treatment Drugs

The Centers for Medicare and Medicaid Services (CMS) has released its quarterly Medicare Physician Fee Schedule (MPFS) and Healthcare Common Procedural Coding System (HCPCS) update for changes effective October 1, 2022.

With this update, several new HCPCS codes for PET radiopharmaceuticals, monoclonal antibodies, and other cancer treatment drugs were announced, while others were deleted. The below is not all inclusive; it is intended to be a highlight of the pertinent changes & updates. To view the full CMS Transmittal outlining MPFS quarterly updates effective October 1, 2022.

Among the new HCPCS codes effective October 1 are codes for fluorodopa f-18 (A9602), a PET radiopharmaceutical used to evaluate adult patients with suspected Parkinsonian syndromes (PS), as well as PLUVICTO™ (A9607), a therapeutic radiopharmaceutical agent indicated for the treatment of adult patients with certain types of prostate-specific membrane antigen (PSMA)-positive prostate cancer. A new code was also created for gallium ga-68 gozetotide (LOCAMETZ®; A9800), a radioactive diagnostic agent indicated for PET of prostate-specific membrane antigen (PSMA) positive lesions.

New HCPCS codes were also created to represent ENJAYMO™ (sutimlimab-jome; J1302), a monoclonal antibody treatment, KIMMTRAK (tebentafusp-tebn; J9274), used to treat patients with unresectable or metastatic uveal melanoma, and CARVYKTI™(ciltacabtagene autoleucel; Q2056), an immunotherapy for treatment of adult patients with relapsed or refractory multiple myeloma. A new code was also created for Releuko™ (filgrastim-ayow; Q5125), a biosimilar used to decrease incidents of infection in patients receiving certain chemotherapy treatments. Additionally, a code was created for Cipla USA, Inc.’s Lanreotide Injection (J1932) which is used to treat adult patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Finally, a new HCPCS code was developed to report OPDUALAG™ (nivolumab and relatlimab-rmbw; J9298), an antibody treatment for patients 12 years of age or older with unresectable or metastatic melanoma.

Industry News August 2022 Figure 1

Due to the new codes created above, the following HCPCS codes will be deleted effective September 30, 2022:

Industry News August 2022 Figure 2

Prostate Cancer Staging – PSMA vs. mp-MRI

A recent study compared 68Ga-PSMA PET/CT (PSMA) and multiparametric prostate MRI (mp-MRI) in locating intraprostatic tumor and locoregional staging.

Physicians utilize a multitude of imaging modalities to diagnose and grade clinically significant prostate cancer. The study, totaling 49 patients, compared PSMA and mp-MRI imaging capabilities in locating intraprostatic tumor and locoregional staging with histopathological results. The study participants underwent both an mp-MRI and PSMA before radical prostatectomy. Additional retrospective parameters evaluated included: pre and post operative PSA, transrectal ultrasound-guided prostate biopsy (TRUS-Bx) ISUO grade, radical prostatectomy ISUP grade, BMI, TRUS prostate volume, mp-MRI tumor mapping, PSMA tumor mapping, pathologic tumor mapping, extraprostatic extension (EPE), seminal vesicle invasion (SVI), lymph node invasion (LNI), and bladder neck invasion (BNI).

The study found that the sensitivity and specificity of the PSMA and mp-MRI were comparable and accurate to detect the location of the intraprostatic index tumor with the mp-MRI being more accurate compared to the PSMA in terms of identifying extraprostatic extension (EPE).

The study concluded that due to its high accuracy in the diagnosis of EPE, an mp-MRI should be considered for high-risk patients before decision-making for nerve-sparing surgery.

Noridian Updates PET Billing & Coverage Policies to Include Illuccix® (Ga-68)

Noridian Healthcare Solutions, the Medicare Administrative Contractor (MAC) for Jurisdiction E (California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands) and Jurisdiction F (Alaska, Arizona, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington, Wyoming) has updated their billing & coding and coverage policies for PET scans. The update adds to the MAC’s policies the new HCPCS code (A9596) for Illuccix® (gallium Ga-68 gozetotide), a drug used for prostate-specific membrane antigen (PSMA) PET scans. Per Noridian’s policy, “PSMA-PET/CT or PSMA-PET/MRI with Gallium 68-ga gozetotide/PSMA-11 may be used to screen patients for Pluvicto™ eligibility per NCCN Guidelines and SNMMI AUC.” The updates are effective as of July 1, 2022.

Inflation Reduction Act Signed into Law

On August 16, President Biden signed into law the Inflation Reduction Act, which will significantly reduce health care costs for millions of Americans. The bill contains many major health policy changes, including:

  • Giving Medicare the power to negotiate prescription drug prices and extend expiring health care subsidies for three years
  • Imposing Medicare penalties on drug companies if they increase prices faster than inflation (to begin in 2023)
  • Limiting out-of-pocket Medicare drug costs to $2,000 a year for medications purchased at a pharmacy, beginning in 2025
  • Free vaccines for Medicare enrollees (currently limited to only certain vaccines, such as COVID-19, pneumonia, and flu)
  • Capping insulin prices at $35 a month for Medicare beneficiaries (beginning in 2023)
  • Extending enhanced federal premium subsidies for Affordable Care Act (ACA) coverage through 2025

The legislation aims to reduce the deficit and will be paid for through new taxes, including a 15% minimum tax on large corporations and a 1% tax on stock buybacks.

The bill will raise over $700 billion in government revenue over 10 years and spend over $430 billion to reduce carbon emissions and extend subsidies for health insurance under the ACA. The rest of the new revenue will be used to reduce the deficit.

First HER2-low Drug Receives Approval

On August 5, 2022, the Food and Drug Administration (FDA) granted approval to the first drug that treats unrespectable and metastatic HER2-low breast cancer.

HER2-low is a subtype of breast cancer in which the HER2 receptors are expressed differently than compared to HER2-negative subtypes.

The newly approved drug, fam-trastuzumab-deruxtecan-nxki, is the first HER2-low breast cancer treatment, providing patients with this subtype breast cancer a new treatment option beyond chemotherapy. In a randomized clinical trial, fam-trastuzumab-deruxtecan-nxki improved overall survival of unresectable or metastatic HER2-low breast cancer patients.

“Having therapies that are specifically tailored to each patient’s cancer subtype is a priority to ensure access to safe and innovative treatments.” – Richard Pazdur, MD, Director of FDA Oncology Center of Excellence