Ten Negotiable Drugs Named – Industry News, September 2023

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10 Negotiable Drugs Named

Under the Inflation Reduction Act (IRA), the Centers for Medicare and Medicaid Services (CMS) gained the authority to negotiate drug prices for the first time and have recently announced the first drugs it plans on negotiating.

Ten, single-source brand-name drugs, that have no therapeutically equivalent generic or biosimilar competition, were selected by CMS for negotiations, based on their total expenditures in the Medicare Part D program. CMS identified the qualifying drugs under Medicare Part D as having been on the market for 7 to 11 years without competition. Some orphan drugs, low-spend drugs, or plasma-derived products were excluded, resulting in selection of the 10 highest ranked negotiation-eligible drugs.

Negotiations will begin in 2023 with the drug companies being given until October 1 to sign an agreement of participation. Those same companies must then submit “manufacturer-specific data” to CMS no later than October 2, for CMS to use for consideration when establishing a “maximum fair price”. By February 1, 2024, CMS will provide its initial maximum fair price offers, with justification, and companies will have 30 days to counteroffer or accept.

The negotiation period will end August 1, 2024. CMS will publish the negotiated maximum fair prices for the 10 drugs a month later, which will take effect beginning January 1, 2026.

To further protect patients from high drug costs, starting in 2025, there will be a $2,000 per year out-of-pocket cap on Medicare Paret D drug costs. CMS will choose up to an additional 15 drugs to negotiate for 2027 and 2028 and up to 20 more drugs each year after that.

FIND Act Gains Support

The Facilitating Access to Innovative Diagnostics (FIND) Act, a bipartisan legislative proposal focused on increasing Medicare reimbursement for diagnostic imaging agents, has gained the endorsement of 123 organizations.

As it currently stands, Medicare reimburses for diagnostic radiopharmaceuticals through a packaged system. Medicare considers diagnostic radiopharmaceuticals “supplies”. The pricing methodology averages higher cost specialized products with more general, widely used low-cost pharmaceuticals. This practice results in Medicare overpaying for the low-cost products and reducing payment for the high-cost products, dissuading providers from utilizing the higher cost, more specialized radiopharmaceuticals; creating barriers to care for those who need newer nuclear imaging agents.  

“Diagnostic radiopharmaceuticals are not interchangeable and substitutions with conventional imaging can impact patient care,” ACR et al.

The FIND Act proposes the Department of Health and Human Services (HHS) pay separately for all diagnostic radiopharmaceuticals with a cost threshold of $500 per day. The budget neutral bill aims to protect Medicare beneficiaries’ access to advanced diagnostic imaging procedures that identify heart disease, neurologic disorders, and cancer in earlier stages.

Supporting organizations include influential groups such as the American College of Radiology (ACR), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Medical Imaging & Technology Alliance (MITA), the American College of Nuclear Medicine (ACNM), the American Society of Radiologic Technologists (ASRT), and the American Society of Neuroradiology (ASNR). Additional supporting organizations include the Michael J. Fox Foundation, Eli Lilly & co., Bracco Diagnostics, GE HealthCare, the Mayo Clinic Department of Radiology and Siemens Healthineers.

“Expanding access to the most advanced and effective PET radiopharmaceuticals would strengthen America’s healthcare system and enhance our ability to diagnose advanced illnesses earlier and with greater accuracy.”
 – Dr. Michael Roarke Chair, Division of Nuclear Medicine for the Mayo Clinic Arizona Department of Radiology

AMA Releases 2024 CPT® Codes

Newly added for the Current Procedural Terminology (CPT®) 2024 code set, the American Medical Association (AMA) has added Spanish language descriptors for over 11,000 medical procedures and services to “bridge language barriers and make health care more inclusive and transparent for patients who speak Spanish.”

Other 2024 changes include 349 editorial changes, including 230 additions, 49 deletions and 70 revisions. CMS sought certain clarifications which prompted changes in defining “substantive portion”, instructions for reporting inpatient or observation care services over two calendar days, and the removal of time ranges from office or other outpatient visit codes to align the format with other E/M codes.

Improve Collection of SDOH Data With Z Codes

Information regarding social determinants of health (SDOH) can be collected and reported utilizing SDOH-related ICD-10-CM diagnosis codes ranging from Z55-Z65. ICD-10-CM Z codes identify non-medical factors that may influence a patient’s health status.

The U.S Department of Health and Human Services defines SDOH as conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. SDOH are grouped into five domains: economic stability, education access and quality, healthcare access and quality, neighborhood and built environment, and social and community context.

Improving the collection and data analysis of SDOH can enhance quality improvement activities, tract factors that influence people’s health, and provide insight into existing health inequities.

The Centers for Medicare and Medicaid Services (CMS) has provided information to outline ways in which Z codes can improve the quality and collection of health equity data.

Cisplatin Supply Returning to Pre-Shortage Levels

After months of severe shortages, the drug cisplatin, used in the treatment for multiple cancers, is close to returning to 100% supply levels.

Due to quality control violations identified by the U.S Food and Drug Administration (FDA) at a key manufacturing plant, cisplatin, along with other cancer therapy drugs, have been in short supply since February of this year. Carboplatin, fluorouracil, fludarabine, methotrexate, capecitabine and docetaxel have also experienced supply issues.

The FDA worked with both Chinese and Canadian pharmaceutical companies to temporarily import cisplatin as well as increase domestic production of cisplatin, carboplatin, and methotrexate. Cisplatin is expected to reach a 100% supply between October and November.

Proposed Raise in MIPS Threshold Sees Opposition from Radiology Groups

Spurred by the Physician-Focused Payment Model Technical Advisory Committee’s (PTAC) request for information, The American College of Radiology (ACR) and the Radiology Business Management Association have shared their  views on the Centers for Medicare and Medicaid (CMS) proposal to raise the Merit-based Payment System (MIPS) performance threshold.

The 2024 Medicare Physician Fee Schedule (MPFS) proposed rule sets to increase the performance threshold to avoid a penalty from 75 points to 82 points. Despite perfect performance in the program, ACR outlined multiple barriers to radiologists’ ability to earn maximum incentives under the current system. These include a limited number of MIPS clinical quality measures equating to 10 points, as well as a lack of acknowledgement to episode-based cost, and the promotion of interoperability measures.

PTAC has held a series of discussions this year exploring the integration of specialty care, including radiology, into population-based models. ACR suggested radiology-focused payment models include screenings for breast, lung, and colorectal cancer, along with follow up cancer staging. ACR pointed out that diagnostic radiology screening and follow-up recommendations, resulting in early detection, are valuable cost saving measures and critical in the patient care path.

PTAC said they will use responses to better advise politicians, payers and ACOs to help further inform about ways to bring value-based care to specialties such as radiology.

Hospitals Still Falling Short on Price Transparency

Results were bleak in a “secret shopper” study of 60 diverse U.S. hospitals, collecting prices for two CMS-required shoppable services as reported in JAMA Internal Medicine.

The study included 20 top-ranked hospitals, 20 safety-net hospitals located in close proximity, and 20 hospitals that did not fit into either category. Conducting the study in a “secret shopper” type investigation, researchers collected hospital’s self-posted online cash prices for brain MRI and vaginal childbirth services. They then had individuals call the institutions and request the cash prices for the same services. 

Out of the 60 hospitals, 47 provided prices for a brain MRI both online and over the phone. Of those 47 hospitals, 26% had differences in prices between the online and phone price by 50% or more, with only 19% having matching prices. Of the 22 hospitals which provided vaginal childbirth prices both online and by telephone, 45% were within 25% of each other while 26% had a 50% or greater difference in price and 14% had prices that matched.

Overall, it was concluded there was a poor correlation between hospitals’ self-posted online prices and the prices offered by telephone. These findings demonstrate the challenges underinsured or uninsured patients face when attempting to shop for healthcare and highlight hospitals’ problems knowing and communicating prices for specific services.