Bipartisan Bill, FIND Act, Aims to Alleviate Cuts to Practice Expense – Industry News, June 2023

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Bipartisan Bill Aims to Alleviate Cuts to Practice Expense

Providing Relief and Stability for Medicare Patients Act of 2023 was introduced to the House representatives on May 25, 2023. The proposal, if enacted, would increase non-facility practice expense (PE) relative value units (RVUs) for procedures performed in office settings that require high-tech devices or equipment.

Three factors that comprise direct PE include clinical labor staff, medical supplies and equipment costs directly associated with a service or procedure. Due to budget neutrality, an increase in payment to one component typically means a decrease in payment to another. The proposed legislation would mitigate cuts resulting from recent clinical labor updates by providing an increase to non-facility PE RVUs for office-base procedures that utilize high-tech medical devices and equipment such as those services often performed by radiation oncologists and radiologists.

The proposed legislation is supported by over 20 physician groups and specialty societies including the American College of Radiation Oncology (ACRO), American College of Radiology (ACR), American Society for Radiation Oncology (ASTRO), and Society of Interventional Radiology (SIR) among many others.

“Due to the budget-neutral nature of the physician fee schedule, specialties with high direct costs will see overall decreases in reimbursement with increases in clinical labor wages. This inevitably results in physicians’ offices closing, increased consolidation, and ultimately, Medicare beneficiaries seeking care in a higher-cost setting.” – Congressman Greg Murphy

FIND Act Looks to Ensure Access to Diagnostic Imaging Drugs

The bipartisan, budget-neutral Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 aims to ensure Medicare beneficiaries have access to advanced diagnostic imaging procedures by directing separate payment for diagnostic radiopharmaceuticals.

Currently, under the Hospital Outpatient Prospective Payment System (HOPPS), the Centers for Medicare and Medicaid Services (CMS) packages diagnostic radiopharmaceuticals as “supplies” into nuclear medicine procedure payments. By doing so, CMS averages the newer, higher cost of specialized products with more widely utilized low-cost radiopharmaceuticals. The average payment methodology results in CMS overpaying for low-cost products while simultaneously reducing payment for higher-cost products, therefore disincentivizing hospitals and providers to utilize certain diagnostic radiopharmaceuticals.

The FIND Act would require the unpackaging of newer, advanced diagnostic radiopharmaceuticals and  implement a separate payment policy for those diagnostic radiopharmaceuticals that exceed a per day cost threshold of $500. The bill aims to maintain budget neutrality while ensuring patients receive medically appropriate tests to ensure accurate diagnoses and treatments.

Drugs & Biologicals Added to Inflation Rebate Program

In early June, the Department of Health and Human Services (HHS), through the Centers for Medicare and Medicaid Services (CMS) announced a total of 43 prescription drugs which coinsurances may be lower through the Inflation Reduction Act (IRA).

To address the rising cost of prescription drugs, The Medicare Prescription Drug Inflation Rebate Program aims to reduce coinsurance for Medicare Part B beneficiaries by discouraging drug companies from increasing prices faster than inflation. CMS released a list of an additional 25 medicines, now totaling 43 prescription drugs and biologicals, that will lower coinsurances. The newly updated list will be effective from July 1 – September 30, 2023. Medicare estimates Part B beneficiaries have the potential to save between $1 and $149 per average dose, depending on individual coverage.

ACR, SNMMI Work to Persuade CMS to Fix Coding Errors

The American College of Radiology (ACR) along with The Society of Nuclear Medicine & Molecular Imaging (SNMMI) have sent multiple joint letters to the Centers for Medicare and Medicaid (CMS) urging them to modify several code edit pairs.

The two agencies are highlighting code edit pairs dating back to 2020 which relate to both single-photon emission computed tomography and SPECT/CT. ACR and SNMMI have urged CMS to review edit pairs for procedures that are typically performed on the same date of service such as radiopharmaceutical therapy by IV administration (CPT® 79101) and SPECT (CPT® 78830-77833) as well as 177 DOTATATE and Lu-177 PSMA.

The letters requested CMS delete procedure-to-procedure (PTP) code edits, including 79101 – 78800, 78801, 78802, 78803, 78804, 78805, 78806, 78807, 78808, 78811, 78812, 78813, 78814, 78815, 78816, 78830, 78831, 78832 and are pushing to make the proposed updates retroactive.

CMS responded to the letters indicating, effective July 1, 2023, column one CPT® code 79101 paired with column two codes 78830, 78831, and 78832 would change from zero to one, allowing a bypass of the edit as supported and appropriate.

ACR and SNMMI are advising providers to keep a listing of affected claims and talk to their local Medicare contractor or payer to request manual payments.

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NCCN® Reports Shortage of Prominent Chemo Drugs Leads to Treatment Complications

The National Comprehensive Cancer Network® (NCCN®) recently published survey results that found more than 90% of cancer centers reported shortages of carboplatin and cisplatin, impacting chemotherapy treatments.

Carboplatin and cisplatin are platinum-based chemotherapies often used in combination to treat a range of cancers including lung, breast, prostate, and gynecologic cancers, as well as leukemias and lymphomas. The shortages of these drugs are being attributed to a pause in production at the factory that produces both drugs following an inspection that raised quality concerns. While awaiting the factory to return to full production, the U.S Food and Drug Administration (FDA) is allowing the temporary importation of some foreign-approved versions of cisplatin from FDA registered factories. 

The NCCN® reported 100% of the cancer centers surveyed were still able to treat patients with cisplatin as prescribed. However, only 64% reported the same for carboplatin with 20% being able to maintain primary treatment regimens for some but not all patients. An additional 16% of survey respondents reported treatment delays due to the need to re-obtain prior authorization for individuals needing modified treatment.  

A call to action in a statement released by NCCN®, highlighted, among other things, the necessity of the payer community to recognize and provide flexible, efficient coverage for alternative therapies for drugs that are not available or in shortage.

LU-177 Production; Ultravist Approval

While the U.S. has seen significant drug shortages, there is uplifting news on the radiopharmaceutical and imaging agent fronts.

ITM Isotope Technologies Munich has opened a lutetium-177 (Lu-177) manufacturing plant, a key component in radiopharmaceuticals (Lu-177 PSMA-617) in which the U.S. has seen recent shortages. The first test runs of the facility are scheduled to begin next month. Once the production facility is fully operational, the anticipated final approvals are expected in the coming year, ITM estimates the manufacturing capacity of the facility will increase tenfold. ITM plans on supplying clinics, pharmaceutical partners, and its own drug pipeline.

Additionally, this month, the U. S. Food and Drug Administration (FDA) approved Bayer’s new imaging agent for contrast-enhanced mammography. Ultravist is an iodine-based injectable used to aid in the visualization of breast lesions in adults. The imaging agent also serves as an adjunct to ultrasound imaging and is the “only contrast agent approved for this indication,” according to Bayer.