Featured story

Waste not, want not. 10% wastage fine should be tried in school cafeterias

The Infrastructure Investment and Jobs Act, signed into law August 10, 2021, contains a little-discussed provision that is getting more attention. Section 90004 stipulates that following each calendar quarter beginning on or after January 1, 2023, the Secretary of Health and Human Services (HHS) will request a refund from manufacturers for discarded amounts of certain single-use packaged, single-source drugs or biologicals and biosimilars that are paid under Medicare Part B. 

Since 2018, Medicare has required the use of modifier JW (Drug amount discarded/not administered to any patient) to indicate drug wastage from single-use packaged drugs on outpatient claims. Claims with drug wastage that exceeds 10% of the total allowed amount per date of service would count toward the quarterly refund.

Exclusions to the requirement include:

Manufacturers will be audited periodically and will incur a 25% civil money penalty for each quarter they fail to comply with the submission of the requested refund. Providers will also be audited to ensure they are accurately reporting modifier JW for discarded amounts from single-use packaged drugs.

Manufacturers of single-use packaged, single-source drugs or biologicals and biosimilars should be considering the impact this section may have for their product’s packaging, pricing, and data collection strategies. 

Contact Milda Kaitz for questions about implications for manufacturers of single-use packaged, single-source products.

Set your product up to reach patients in need.
Patients should be at the center of strategies to commercialize rare and orphan disease treatments. Download now to read more about what questions to consider to set up your product for maximum reach and impact.

Legislative update

Coding corner

The early bird gets the worm. Introduction to ICD-11

February 11, 2022, marked the official release of the International Classification of Diseases, 11th Revision (ICD-11) (2022) for worldwide implementation, with 35 countries already using it (though not in the US yet). ICD is the international standard for health data, clinical documentation, and statistical aggregation. The detail provided in ICD-11 codes will allow governments across the globe to propose effective public health policies and measure their impact—a benefit that is front of mind given the ongoing COVID-19 pandemic and an ongoing need to quantify value in healthcare.

Key features
A key component of this iteration of ICD is that it is completely digital, allowing for on- and off-line utilization. The 11th revision of ICD contains over 17,000 diagnostic categories with more than 120,000 medical index terms. The smart coding algorithm interprets over 1.6 million terms. ICD-11 has multilingual browsers, coding tools, and integrated application programming interface (API) tools that facilitate implementation. A translation tool supports international use by ensuring consistent translations.

Use
Some of the reported benefits of ICD-11 include use in: 

• Mortality and morbidity certification, coding, and reporting
• Researching and performing clinical trials and epidemiological studies
• Primary care reporting, clinical recording, research, and patient safety
• Assessing functioning
• Case-mix and diagnosis-related grouping
• Coding traditional medicine conditions 
• Assessing and monitoring the safety, efficacy, and quality of care
• Interoperability standard in WHO digital guidelines and for digital documentation of COVID-19 certificates 
• Cancer registries; grade and stage coding for cancers
• More efficient clinical documentation
• Antimicrobial resistance surveillance
• Updated diagnostic recommendations for mental health conditions
• Rare disease coding
• Support for perinatal and maternal coding

To date, the US has not announced transition plans for ICD-11. With ICD-11 only covering diagnosis coding, there is much to be learned regarding how the US will address procedure coding.

COVID-19 update

Ebook: Virtual Drug Commercialization

The success of a manufacturer’s product depends heavily on provider uptake, patient and provider access to the product, and demonstrating product value to payers. And while all these touchpoints may happen at various stages of the product life cycle, they’ve all been impacted by COVID-19. 

Download now for actionable guidance on overcoming the engagement barriers COVID-19 has presented for the critical groups manufacturers want to reach: providers, payers, and patients.

Regulatory Update

Talk is cheap, unless you’re dealing with one of those conditions in the updated DSM-5

Last Friday, the American Psychiatric Association announced the release of the updated Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with text revisions (DSM-5-TR). A group of over 200 experts began working on these changes in 2019, reviewing literature from the past 9 years while cross-checking text to remove outdated material. No conceptual changes were made to the criteria sets, but this edit did include clarifications to certain diagnostic criteria. 

One new diagnosis code was created to report prolonged grief disorder (F43.8); detailed criteria for this can be found here.

A brief synopsis of additional changes:

Some diagnostic criteria were reviewed and adjusted for further clarification. The text changes occur in the following 11 diagnoses:

While overall the changes relate to semantics only, please take note of whether you have any provider or patient education materials that may need updating. Please contact Milda Kaitz if you want to see if these changes will affect your products.

Information buffet (AKA, other stuff that caught our attention)

Heard on the street

“Sewage surveillance is an effective and relatively low-budget enterprise, less reliant on human whim….

“Dozens of research projects around the country have shown that the method can be used to accurately track COVID-19 trends over time. And because people shed COVID-19 in their feces before they show symptoms, upticks and drop-offs in neighborhood- and community-level infections can appear in sludge several days before they show up in tests.”

Source: “Health officials see bright future in poop surveillance,” Kaiser Health News, March 24

Policy by numbers

152

Upcoming meetings and conferences

 AMCP 2022

March 29–April 1, 2022, Chicago, IL
Join AmerisourceBergen at the 2022 Academy of Managed Care Pharmacy conference in Chicago, IL. As managed care pharmacy is continuously changing, we believe it’s important to connect during this unprecedented time. It’s also critical to keep up to date on what’s happening in the industry. Meet with our team to discuss solutions for your product’s commercialization journey.

Career opportunities

Associate Director, GHEOR Staffing Solutions (remote, US)

Are you looking to make a difference in a patient’s life? At AmerisourceBergen, you will find an innovative and collaborative culture that is patient focused and dedicated to making a difference. This position is responsible for providing support to Xcenda’s clients specific to their staffing needs (eg, addressing client capability or capacity-related gaps by attending client meetings, developing strategic plans, and implementing research engagements as an on-site or remote team member) in the health economics and outcomes research and/or market access space.

Assistant Director, Oncology Strategy and Communication (remote, US)

The Oncology Strategy and Communications Assistant Director serves as an expert clinical resource for the development of clinical materials and implementation of medical communications, health outcomes and evidence generation, and market research across multiple clients and Xcenda teams. This role is imperative to Xcenda as it contributes in creating, educating, and inspiring our dynamic team of researchers to create their highest-quality output attainable while upholding Xcenda’s core mission and vision.

Assistant Director, Clinical Data Management (remote)

The Assistant Director, Clinical Data Management is responsible for independently leading the clinical data management aspects of prospective clinical studies. The Assistant Director, Clinical Data Management has thorough knowledge of FDA regulations and industry standards, possesses strong technical skills, and can work collaboratively with team members to assure that data management functions are performed in compliance with regulations and according to study protocol.

Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.

Featured contributors

Advisory board:

Willis Chandler
SVP and President | Manufacturer Services and Commercial Solutions | AmerisourceBergen

Tommy Bramley, PhD, RPh
SVP, Global Consulting | AmerisourceBergen

Rita Norton
SVP, Government Affairs and Public Policy | AmerisourceBergen

Ana Stojanovska
Vice President | Commercial Consulting | AmerisourceBergen

Contributing authors:

Rebecca Dudla | Milda Kaitz | Dawn Monegato | Scott Shields

Production:

Laurie Kozbelt | Ellen Olson