Below is a summary of the changes we implemented on Tuesday, 11/26 in conjunction with the recent Special Master guidance:
- Asthma - Clinical vs. Physician Diagnosis: The clinical diagnosis of Asthma (“f/n 13” of the Allocation Methodology), if based on symptoms such as shortness of breath, wheezing, or the use of albuterol, caps the claimant’s category at severity level A1. To qualify for severity levels A2 and above, the claimant must provide a physician diagnosis of Asthma. If asthma-related records exist but lack a documented initial diagnosis date, the claimant cannot use the clinical symptom criteria to establish a new onset diagnosis date. [Guidance Memorandum, November 11, 2024, Topic #5]
- COPD and Asthma New Onset: Claimants must provide a documented initial Asthma or COPD diagnosis, including the diagnosis date, to establish the case as new onset. Without this documentation, the claimant can only qualify for EPP or FEP Worsening if they meet the criteria for worsening. This applies to claimants who have a diagnosis date that is not the initial diagnosis date; if pre-product use records references Asthma or COPD, the claimant must have been diagnosed before product use and can only qualify for EPP or FEP Worsening. [Guidance Memorandum, November 11, 2024, Topic #4]
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EPP Worsening Criteria: Additional guidance has been provided on alternative ways for proving worsening in the EPP, where an initial diagnosis date is not required. We have updated the process on Pattern to reflect this additional criterion.
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Albuterol use documented in at least 3 prescription records, or medical records noting albuterol use, in any given year after first Recalled Device Usage.
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Increased frequency of medical visits, defined as two or more visits in any given year for shortness of breath or wheezing, occurring after the initial usage of the Recalled Device.
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- Pattern will also include any records of explicit exacerbations or hospitalizations related to the qualifying injury after first Recalled Device Usage as evidence to support qualification for worsening. [Guidance Memorandum, November 11, 2024, Topic #3]
- Injury Override Update: Previously, when an Injury Override was applied on Pattern for asthma cases using albuterol, shortness of breath (SOB), wheezing, or PFT results, our calculations would remove the earliest diagnosis date from the case, as we were uncertain about its reliability. This has now been updated: if the injury override applies to the same injury, the earliest diagnosis date will remain in the case.
- Qualifying Cancer Detection: We have enhanced our detection of cancers, including Hurthle Cell Cancer, which is now mapped to Well Differentiated Thyroid Cancer for calculation purposes. Your inventory has been reprocessed, and if Hurthle Cell Cancer is found in the records, it will be reflected in the profile.
- Oropharynx Points Update: The point values for oropharynx cases have been corrected and will now display the accurate point totals, rather than zero.