New Alzheimer’s Drug Approved for Clinical Trials

Wrinkled woman's hands holding stick

Alzheimer’s disease is a currently irreversible brain disorder that progressively degrades memory, cognitive function, and the ability to carry out tasks of daily living. It is the number one cause of dementia in older Americans, contributing to 60-80 percent of cases.

On Jan. 11, 2022, the Centers for Medicare & Medicaid Services (CMS) approved the high-profile drug Aduhelm for treatment of Alzheimer’s disease. However, this coverage policy was released with certain specific circumstances in which the drug may be used.

Over 6 million older Americans have Alzheimer’s disease; this prevalence is expected to rise to 14 million by 2060, barring effective interventions (such as lifestyle changes, treatment of risk factors, and possible combinations of drugs). It is the sixth-leading cause of death in the United States. Though concerns have been raised over the accelerated approval of the drug Aduhelm, the anticipation of its availability is certainly no surprise, considering the statistics.   

Aduhelm gained attention in 2021 as the first monoclonal antibody for treating Alzheimer’s disease. Not only did the treatment draw attention to the Food and Drug Administration (FDA) approval process (and the speed at which it was gaining momentum), but the initial established list price was also $56,000, raising the Medicare premium by $22 for 2022. In December, this price was reduced by 50 percent. An FDA advisory panel did not recommend the approval, as the risk related to treatment had not been fully vetted. The center for Clinical Standards and Quality with CMS suggested evidence of possibly harmful side effects, such as brain bleeds, headaches, dizziness, and falls. 

Yet Aduhelm secured preliminary coverage on Jan. 11, 2022 for patients enrolled in an approved clinical trial that must be conducted in an outpatient setting. Coverage would also include related services such as positron emission tomography (PET) scans. However, there are parameters regarding the frequency of PET scans and coverage.

Effective Jan. 1, 2022, A HCPCS level II code, JO172, was established for reporting the injection of Aduhelm in 2-mg doses. This is the smallest amount that could be billed in multiple units to accommodate a variety of doses, thus making accuracy in reporting the amount used paramount. Revenue code 636 is used when billing the approved JO172 code.

Again, the patient must be enrolled in an approved clinical trial and meet certain specific criteria to receive the new drug; the patient must have a clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease dementia, and evidence of amyloid pathology consistent with Alzheimer’s disease.

In addition, the patient must not have any neurological or other secondary medical condition that may significantly contribute to cognitive decline. Any medical conditions other than Alzheimer’s disease may increase significant adverse events.

Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, provided outside of the CMS-approved randomized controlled trials and trials supported by the National Institutes of Health (NIH), are nationally non-covered.

Be aware that the new HCPCS code, J0172, for the drug treatment is effective from Jan. 1, 2022 to March 31, 2022, and is subject to change during a 90-day comment period. Public comment is welcome until March 31, 2022.

Those organizations that treat a population with high prevalence of Alzheimer’s should take note that the clock is ticking; we have less than two months to comment on this drug and its use.

Programming Note: Listen to Susan Gatehouse report this story live today during Talk Ten Tuesdays.

Facebook
Twitter
LinkedIn

Susan Gatehouse, RHIT, CCS,CPC, AHIMA-Approved ICD-10-CM/PCS Trainer

Susan Gatehouse is the founder and chief executive officer of Axea Solutions. An industry expert in revenue cycle management, Gatehouse established Axea Solutions in 1998, and currently partners with healthcare organizations across the nation, to craft solutions for unique challenges in the dynamic world of healthcare reimbursement and data management.

Related Stories

I am Just a Bill

I am Just a Bill

Today is election day.  I wanted to talk about the process by which laws are passed and regulations created in healthcare. Recently, the fall of

Read More
Washington Carries On

Washington Carries On

As the November elections neared, you might have expected Washington to slow to a crawl amidst campaigning and uncertainty about the future. However, the show

Read More

Leave a Reply

Please log in to your account to comment on this article.

Featured Webcasts

Enhancing Outcomes with CDI-Coding-Quality Collaboration in Acute Care Hospitals

Enhancing Outcomes with CDI-Coding-Quality Collaboration in Acute Care Hospitals

Join Angela Comfort, DBA, MBA, RHIA, CDIP, CCS, CCS-P, as she presents effective strategies to strengthen collaboration between CDI, coding, and quality departments in acute care hospitals. Angela will also share guidance on implementing cross-departmental meetings, using shared KPIs, and engaging leadership to foster a culture of collaboration. Attendees will gain actionable tools to optimize documentation accuracy, elevate quality metrics, and drive a unified approach to healthcare goals, ultimately enhancing both patient outcomes and organizational performance.

November 21, 2024
Comprehensive Inpatient Clinical Documentation Integrity: From Foundations to Advanced Strategies

Comprehensive Outpatient Clinical Documentation Integrity: From Foundations to Advanced Strategies

Optimize your outpatient clinical documentation and gain comprehensive knowledge from foundational practices to advanced technologies, ensuring improved patient care and organizational and financial success. This webcast bundle provides a holistic approach to outpatient CDI, empowering you to implement best practices from the ground up and leverage advanced strategies for superior results. You will gain actionable insights to improve documentation quality, patient care, compliance, and financial outcomes.

September 5, 2024
Advanced Outpatient Clinical Documentation Integrity: Mastering Complex Narratives and Compliance

Advanced Outpatient Clinical Documentation Integrity: Mastering Complex Narratives and Compliance

Enhancing outpatient clinical documentation is crucial for maintaining accuracy, compliance, and proper reimbursement in today’s complex healthcare environment. This webcast, presented by industry expert Angela Comfort, DBA, RHIA, CDIP, CCS, CCS-P, will provide you with actionable strategies to tackle complex challenges in outpatient documentation. You’ll learn how to craft detailed clinical narratives, utilize advanced EHR features, and implement accurate risk adjustment and HCC coding. The session also covers essential regulatory updates to keep your documentation practices compliant. Join us to gain the tools you need to improve documentation quality, support better patient care, and ensure financial integrity.

September 12, 2024

Foundations of Outpatient Clinical Documentation Integrity: Best Practices for Accurate Coding and Compliance

This webcast, presented by Angela Comfort, DBA, RHIA, CDIP, CCS, CCS-P, a recognized expert with over 30 years of experience, offers essential strategies to improve outpatient clinical documentation integrity. You will learn how to enhance the accuracy and completeness of patient records by adopting best practices in coding and incorporating Social Determinants of Health (SDOH). The session also highlights the role of technology, such as EHRs and CDI software, in improving documentation quality. By attending, you will gain practical insights into ensuring precise and compliant documentation, supporting patient care, and optimizing reimbursement. This webcast is crucial for those looking to address documentation gaps and elevate their coding practices.

September 5, 2024

Trending News

Featured Webcasts

Patient Notifications and Rights: What You Need to Know

Patient Notifications and Rights: What You Need to Know

Dr. Ronald Hirsch provides critical details on the new Medicare Appeal Process for Status Changes for patients whose status changes during their hospital stay. He also delves into other scenarios of hospital patients receiving custodial care or medically unnecessary services where patient notifications may be needed along with the processes necessary to ensure compliance with state and federal guidance.

December 5, 2024
Navigating the No Surprises Act & Price Transparency: Essential Insights for Compliance

Navigating the No Surprises Act & Price Transparency: Essential Insights for Compliance

Healthcare organizations face complex regulatory requirements under the No Surprises Act and Price Transparency rules. These policies mandate extensive fee disclosures across settings, and confusion is widespread—many hospitals remain unaware they must post every contracted rate. Non-compliance could lead to costly penalties, financial loss, and legal risks.  Join David M. Glaser Esq. as he shows you how to navigate these regulations effectively.

November 19, 2024
Post Operative Pain Blocks: Guidelines, Documentation, and Billing to Protect Your Facility

Post Operative Pain Blocks: Guidelines, Documentation, and Billing to Protect Your Facility

Protect your facility from unwanted audits! Join Becky Jacobsen, BSN, RN, MBS, CCS-P, CPC, CPEDC, CBCS, CEMC, and take a deep dive into both the CMS and AMA guidelines for reporting post operative pain blocks. You’ll learn how to determine if the nerve block is separately codable with real life examples for better understanding. Becky will also cover how to evaluate whether documentation supports medical necessity, offer recommendations for stronger documentation practices, and provide guidance on educating providers about documentation requirements. She’ll include a discussion of appropriate modifier and diagnosis coding assignment so that you can be confident that your billing of post operative pain blocks is fully supported and compliant.

October 24, 2024
The OIG Update: Targets and Tools to Stay in Compliance

The OIG Update: Targets and Tools to Stay in Compliance

During this RACmonitor webcast Dr. Ronald Hirsch spotlights the areas of the OIG’s Work Plan and the findings of their most recent audits that impact utilization review, case management, and audit staff. He also provides his common-sense interpretation of the prevailing regulations related to those target issues. You’ll walk away better equipped with strategies to put in place immediately to reduce your risk of paybacks, increased scrutiny, and criminal penalties.

September 19, 2024

Trending News

Prepare for the 2025 CMS IPPS Final Rule with ICD10monitor’s IPPSPalooza! Click HERE to learn more

Get 15% OFF on all educational webcasts at ICD10monitor with code JULYFOURTH24 until July 4, 2024—start learning today!

👻Spooky Sale is Back!👻 Get 31% off all three Medlearn brands, using code SPOOKY24.