On May 9, 2024, BrownGreer PLC was appointed by the Court as the Settlement Administrator for the Philips Respironics Personal Injury Settlement Program (Document 2779). In this role, BrownGreer is responsible for coordination and implementation of all aspects of the Settlement Program including: application of the Allocation Special Master’s Methodology for the claims review process; distributing settlement proceeds; and any other administrative duties outlined within the Master Settlement Agreement and orders of the Court.  

In the same Order that appointed BrownGreer PLC as the Settlement Administrator, the Court appointed Matt Garretson to serve as the Allocation Special Master and is tasked with creating an Allocation Methodology to calculate the settlement amount for each Eligible Claimant, including a process for reviewing and determining any Extraordinary Injury Fund (“EIF”) applications.

The Court appointed Judge Diane M. Welsh (retired) to serve as the Settlement Special Master. She will decide any potential disputes between the Parties to the Master Settlement Agreement (“MSA”) about its terms and provisions. Specifically, Judge Welsh will resolve any challenges to the Identification Order Report and any challenges to the Settlement Administrator’s calculation of the Participation Levels after the Registration process concludes.

On May 15, 2024, the Court appointed Wolf Global Compliance (“WGC”) to serve as the Lien Administrator for the Settlement Program. WGC shall be responsible for the duties set forth in the MSA assigned to the Lien Administrator, including the negotiation and resolution of Liens asserted by Lienholders, including global resolutions, and such other duties as Plaintiffs’ Negotiating Counsel and the Lien Administrator so agree.

You may contact the Settlement Administrator in the following ways:

By Email: SettlementAdministrator@RespironicsPISettlement.com

By Mail: Philips Respironics Personal Injury Settlement

               P.O. Box 25368

               Richmond, VA 23260

Beginning on June 14, 2021, Philips RS announced recalls of certain CPAP, BIPAP, and ventilator products (“Recalled Devices”), resulting in personal injury claims against the Philips Defendants for alleged injuries sustained while using one or more of the Recalled Devices.

Plaintiffs and the Philips Defendants reached an agreement for the Philips Defendants to pay $1.075 billion dollars to resolve personal injury litigation related to the Recalled Devices. This will resolve all Philips Respironics CPAP-related lawsuits filed in the federal multidistrict litigation (MDL 3014) before the Honorable Judge Joy Flowers and those filed in Massachusetts state court. The Settlement Program also resolves any tolled or unfiled claims against the Philips Defendants as set forth in the MSA.

No. The Philips Defendants deny liability and maintain that use of the Recalled Devices did not cause any injuries.

Any United States Citizen or Resident who, as of the applicable Identification Order Declaration Deadline, alleges a Qualifying Injury caused by their use of one or more Recalled Devices. This includes any individual who: (1) retained counsel on or before 4/29/24 and is included on a timely-submitted Identification Order Declaration; or (2) is a pro se plaintiff who has filed a Personal Injury Claim or Claims in the MDL Court or Massachusetts state court alleging a Qualifying Injury or submits a timely Identification Order Declaration. There are no exceptions for law firms who retained their clients after 4/29/24. Those clients are ineligible to participate in this private Settlement Program and must pursue other available avenues of relief. The Settlement Administrator cannot give legal advice.

The deadline to complete and submit an Identification Order Declaration to join the Program was June 21, 2024. Anyone not included on a submitted Declaration by the ID Order deadline is unable to register for or participate in the settlement absent the express agreement and consent of the Parties to the MSA.

This private Settlement Program is a fixed fund and is for Eligible Claimants with existing Qualifying Injuries diagnosed by April 29, 2024. We will not allow into the Settlement Program any clients who were only diagnosed with a Qualifying Injury after 4/29/24. This private settlement program does not waive “future” injuries.

No. The Settlement Administrator will apply the Allocation Methodology to each case individually. Claimants need to submit their own settlement materials to participate and cannot rely on others to do so.

MSA is shorthand for Master Settlement Agreement. The Personal Injury Master Settlement Agreement dated May 9, 2024, is the agreement between the Parties which details the settlement terms and the mechanisms to administer the Settlement Program.

On May 9, 2024, Judge Conti entered an Identification Order in the MDL Court (Doc. No. 2770) establishing requirements for pro se Claimants and Primary Counsel on behalf of all represented Claimants to provide certain information to identify all potential Eligible Claimants to the Settlement Administrator (in the form of an Identification Order Declaration). Complete, accurate, and timely submission of this information is a requirement not only of the Order, but also the first step for anyone who may want to participate in the Settlement Program. Loss of consortium claims are not Eligible Claimants and are not to be included on a Declaration.

The deadline for submission of an Identification Order Declaration was June 21, 2024.

Note: The Massachusetts State Court also entered an Identification Order on May 20, 2024. The requirements are identical to the MDL Identification Order, with June 21, 2024, as the deadline for compliance.

Each pro se Eligible Claimant and Primary Counsel on behalf of each of their Eligible Claimant clients, must provide:

(1) Claimant’s Name;

(2) Claimant’s complete Social Security Number;

(3) Claimant’s Email Address (if any);

(4) Claimant’s Mailing Address;

(5) Claimant’s Date of Birth;

(6) Court where lawsuit was filed (if applicable);

(7) Docket Number for the filed lawsuit (if applicable);

(8) MDL-C Filing Number (if the Claimant was ever registered in MDL-Centrality); and

(9) Qualifying Injury.

No. The only information required in the Identification Order Declaration is selection of a Qualifying Injury (or the most severe Qualifying Injury, if more than one) that is alleged by the Eligible Claimant. Documentary proof of the Qualifying Injury will be required during the Registration phase of the Settlement Program.

All Declarations were due by 11:59 p.m. ET on June 21, 2024.

Whichever firm will process the Claimants through the Settlement Program as Primary Counsel needs to submit all the Eligible Claimants in that firm’s ID Order Declaration submission. MDL Centrality will list each Eligible Claimant’s Primary Counsel according to that Declaration and will notify firms if the same Eligible Claimant is submitted by more than one firm to have that overlap in representation resolved. 

BrownGreer populated what it could in each Eligible Claimant List from the information available in the Census Registry. If provided, the Census data was prefilled with Primary Counsel name, Primary Counsel’s Email Address, Claimant First and Last Name, the Claimant’s Social Security Number, Claimant Email Address, Claimant Mailing Address, Date of Birth, and MDL Centrality Plaintiff ID.

Your firm’s Census Registry submissions may be found on the Census Details Report. To access the report, select Reporting at the top of the CPAP home page in MDL-Centrality and then click the blue Census Details Report hyperlink (MDL 1206). Select which population you want displayed using the Section menu, and then click View Report. To download the report into MS Excel format, click the blue Save icon and then select Excel. 

Failure to submit an Identification Order Declaration is a violation of the Courts’ Orders. In addition, any person who is not included on an Identification Order Declaration will be ineligible to participate in the Settlement Program.  Remember, including an Eligible Claimant on an Identification Order Declaration list is not a commitment by that Claimant to join the Settlement Program, but it is a prerequisite to being able to join the Settlement Program in the Registration phase that will follow the Identification Order Declaration phase.

For pro se plaintiffs who have filed a lawsuit in the MDL Court or Massachusetts Court alleging a personal injury claim caused by use of one of the Recalled Devices, they are exempt from complying with the Identification Order requirements, but they must register to participate in the Settlement Program by the January 31, 2025 Registration Deadline.

Certain devices with the brand name REMSTAR Auto were included in the recall. Note that REMStar SE (not Auto) is not a recalled device and is not included in the settlement. This is the website to search for a Philips Serial Number that was subject to the product recall that may assist in completing the Recalled Device Information during Registration: https://www.respironicspisettlement.com/home/seriallookup. 

No, claims will not be released unless a Claimant is Eligible, becomes a Registered Claimant, and the Registration is not determined to be Deficient.

If a Claimant does not have a Qualifying Injury, they are an Ineligible Claimant and must NOT be included on an Identification Order Declaration List. This is an opt-in settlement, so you do not need to do anything to opt-out, but you must comply with all applicable Court orders, including the Docket Management Order.

No, the Settlement does not require Claimants have a filed complaint to be eligible.

Yes, those fields should only be completed if applicable.

Yes.

No. The release does not include cancers developed in the future.

Eligible Claimants who wish to register in the Program must be included on an Identification Order Declaration that meets all the requirements set forth in the MSA and the May 9, 2024 Identification Order. The deadline to submit an Identification Order Declaration was June 21, 2024. We cannot accept Declarations submitted after that date, and any individual who failed to submit a Declaration by that date will be ineligible to register for or participate in the settlement.

For those individuals that submitted a timely and complete Identification Order Declaration, Registration materials will be made available on July 25, 2024, and must be submitted by the January 31, 2025 Registration Deadline.

By the January 31, 2025 Registration Deadline, each Eligible Claimant wishing to participate in the settlement, or their Primary Counsel, must submit:

(1) The Registration Form provided on your Settlement Portal signed by the Eligible Claimant;

(2) A Release signed by the Eligible Claimant and any Derivative Claimant(s); and

(3) A Stipulation of Dismissal with Prejudice for any Eligible Claimant with a previously-filed personal injury lawsuit.

By the February 20, 2025 Supplementation Deadline, each Eligible Claimant wishing to participate in the settlement, or their Primary Counsel, must submit any final changes to Registration Form answers and/or provide additional Record Sets and documents to support any timely submitted Registration Packet, including:

(1) Proof of use of a Recalled Device; and

(2) Proof of the alleged Qualifying Injury through diagnosis and/or treatment records.

Before payment of any eligible claim, each Claimant must also provide proof that the Eligible Claimant is a U.S. citizen or resident, unless satisfied through the Identity Verification Process.

The Registration Form, Release, and Lien Disclosure and Authorization Form must be signed by the Eligible Claimant. Counsel cannot sign on behalf of the Eligible Claimant. A wet ink signature is not required on any of the Registration documents. If necessary, Primary Counsel will complete and sign the Stipulation of Dismissal on behalf of Eligible Claimants.

The Qualifying Injuries are established in the Settlement Allocation Methodology dated July 23, 2024, that is available for review on the Settlement Program Portals.

Qualifying Respiratory Injuries:

(1) Asthma, new onset;

(2) RADS;

(3) COPD, new onset;

(4) Emphysema;

(5) Bronchiectasis;

(6)  Bronchitis*, chronic and persistent;

(7) Lung obstruction, new onset through PFTs;

(8) Bronchiolitis Obliterans;

(9) Pulmonary Fibrosis/Interstitial Lung Disease;

(10) Pulmonary Fibrosis/Usual Interstitial Pneumonitis;

(11) Pulmonary Fibrosis/Nonspecific Interstitial Pneumonitis;

(12) Pulmonary Sarcoidosis;

(13) Pneumonitis** / Acute Interstitial Pneumonitis;

(14) Pneumonitis** / Acute Respiratory Distress Syndrome (ARDS);

(15) Pneumonitis** / Hypersensitivity Pneumonitis (HP);

(16) Pneumonitis** / Non-infectious Pneumonitis;

(17) Pneumonitis** / Cryptogenic Organizing Pneumonitis (a/k/a Bronchiolitis Obliterans

Organizing Pneumonitis or BOOP);

(18) Pneumonitis** / Acute Eosinophilic Pneumonitis (AEP).

* This injury type specifically excludes any acute or non-persistent bronchitis.

** These injury types specifically exclude any infectious pneumonia or infectious pneumonitis (including those that are viral, bacterial, or fungal).

Worsening Qualifying Respiratory Injuries:

(19) Asthma, worsening;

(20) COPD, worsening.

Qualifying Cancers:

(21) Lung Cancer;

(22) Acute Myeloid Leukemia (AML);

(23) Chronic Myeloid Leukemia (CML);

(24) Mucosa Associated Lymphoid Tissue (MALT) of the air-pathway lymphoid tissue;

(25) Thyroid Cancer;

(26) Oropharynx Cancer;

(27) Nasal Cavity/Sinus Cancer;

(28) Nasopharynx Cancer;

(29) Esophageal Cancer;

(30) Oral Cavity Cancer;

(31) Salivary Cancer;

(32) Larynx Cancer;

(33) Hypopharynx Cancer.

Any individual alleging a non-Qualifying Injury who wishes to litigate outside the Settlement Program must comply with the Docket Management Order for Claims of Litigating Plaintiffs entered by Judge Conti in the MDL Court on May 9, 2024 (Doc. No. 2769).

Each case will be evaluated according to the adopted Settlement Allocation Methodology. Eligible Claimants must submit proof of use of a Recalled Device and medical records that support the alleged Qualifying Injur(ies) (the Usage Record Set and Injury Record Set under the Allocation Methodology). Every participant in the Settlement Program will receive a notice detailing their settlement award determination. Registered Claimants can log into their Settlement Portal to view the adopted Settlement Allocation Methodology.

Yes. Submission of medical records relating to the alleged Qualifying Injury or Injuries (the Injury Record Set) will be part of the Registration process. The Allocation Special Master has established criteria for submission of medical records and additional claims materials under the Settlement Allocation Methodology to receive a settlement award.

The Settlement Administrator and those who support its review process apply the adopted Settlement Allocation Methodology to all the data and timely-submitted materials on every Eligible Claimant to determine the Award outcome on a claim. If an Eligible Claimant requests Reconsideration, the claim goes back to the Settlement Administrator to be re-reviewed. We will issue a Final Notice After Reconsideration based on those results, which cannot be appealed.

No. Submission of a Registration Form and Release by a Claimant electing to participate in the Program is irrevocable. No Registered Claimant may under any circumstances or reason withdraw a Registration Form or accompanying materials, request the return of his/her Release or dismissal with prejudice, or otherwise withdraw from the Program. See MSA Section 3.10 for more information on this topic.

Yes. Pursuant to Section 2.8 of the MSA, the Philips Defendants agree to the tolling of any and all time limitations for filing or pursuing a Personal Injury Claim for all claimants included on the Identification Order Report. This tolling period expires 14 days after the expiration of the Philips Defendants’ Termination Rights. With the extended Registration Deadline, that expiration date for Termination Rights is now 2/28/25, meaning the tolling period runs until 3/14/25.

Yes. Claimants may make a Request for Reconsideration to ask the Allocation Special Master to reconsider the claim based on information already on file with the Program, but only if you believe the Settlement Program has: (1) made a clerical error; (2) misapplied or misinterpreted the dates of use of a Recalled Device; or (3) missed contemporaneous diagnosis or treatment records for a Qualifying Injury. See Section VII of the Allocation Methodology for more information about the Reconsideration process. No new documentation may be submitted with a Reconsideration request.

The Extraordinary Injury Fund Methodology and Exemplar Application were posted to the Settlement Portal on February 20, 2025. Refer to these resources for more information about submitted an EIF Application.

Since it is not known at this time i) how many Claimants will Register and have a Qualifying Injury, ii) how many Registered Claimants will elect the EPP vs FEP, or iii) the volume and mix of the Primary and Secondary Qualifying Injuries and associated Severity Levels for the FEP Registered Claimants, the Point Dollar Value cannot be forecast. There are, however, a few concepts that might be helpful:

(1) The possible Points for FEP Claimants range from a low of 25 Points to a max of 2,750 Points.

(2) If 40,000 Claimants register for the Settlement Program and qualify for a Settlement Amount, the per case average Settlement Amount for all Claimants would be slightly over $25,000 ($1,075,000,000 / 40,000 (estimated Registered Claimants who qualify for an award) = $26,875). If 30,000 Claimants register and qualify for a Settlement Amount, the per case average Settlement Amount for all Claimants would be closer to $35,000.

(3) This per case average will vary depending upon the actual number of qualifying Claimants (and their injury types), which cannot be determined at this time.

(4) FEP Registered Claimants who qualify for at least Severity Level 1 will receive a minimum gross Settlement Amount of $4,000 (before deductions for contractual attorneys’ fees, case costs, the court-ordered Common Benefit Assessment, and any medical or other liens).

(5) It is likely (but not certain) that FEP Claimants who qualify only for base-level Severity Level 1 and Severity Level 2 points (or, depending upon the circumstances, perhaps higher), without significant Point-increasing Adjustments would receive greater compensation by electing to participate in the EPP. The FEP likely is more attractive to Claimants with more severe injuries and/or those who qualify for multiple of the Point-increasing Adjustment Factors such that they qualify for several hundred Points (e.g. greater than 350-500 Points).

(6) Soon we will post a calculator that will enable Counsel and Claimants to calculate their likely Final Point Total using their own inputs (see page 13 of the Allocation Methodology).

A bookmark is a way to create a link to a specific page in a document in a PDF file. The Allocation Methodology requires any Record Sets provided as part of Registration to have bookmarks to the relevant pages (i.e., the page with the Qualifying Diagnosis, the page with the treatment or test demonstrating a particular Severity Level, and the pages demonstrating the relevant Adjustments, such as smoking history, etc.).

Bookmarks must be added to the documentary proof before you upload it. To add a bookmark to a PDF, right-click on the page in the document you wish to bookmark and select “Add bookmark” from the drop down menu. You can then name the bookmark in the Bookmarks details menu that pops up on the screen. Continue this process to add more bookmarks to other relevant pages. Note that bookmarking is available in Adobe Acrobat Standard and Professional. The bookmarking tool is not available in Adobe Acrobat Reader (free version).

No, they are not subject to change.

EPP and FEP awards are coming from the same Settlement Fund which will be funded if the Participation Level defined in the Master Settlement Agreement is met. Because the EPP provides for fixed payment amounts and a simplified record submission and review process, they will be processed faster than the FEP Claimants. That said, the difference in timing will be a matter of months (not years).

Bookmark all pages necessary to establish the Qualifying Injury and Severity Level for which you are trying to qualify the Claimant.

Claims for Claimants who died from a Qualifying Injury will be eligible for additional consideration from the Extraordinary Injury Fund ("EIF"). The application requirements and categories for the EIF will be published in a separate EIF Methodology.

A new Qualifying Injury first diagnosed after 4/29/2024 (not a worsening case, but a totally new Qualifying Diagnosis), may be submitted into the EIF fund. So, for instance, a Claimant registers as COPD and has records of that diagnosis which predate 4/29/2024 and then is diagnosed with a Qualifying Cancer after 4/29/2024 but before 1/31/2025. That Claimant will be able to submit the cancer claim into the EIF for separate consideration.

Claims will not be released unless a Claimant qualifies for a payment. In such instances, the Release will be returned to Counsel for the Claimant.

The Settlement Administrator will attempt to verify the Claimant’s U.S. Citizenship through national databases using the name, date of birth, and Social Security Number provided during Registration. If we are able to confirm U.S. Citizenship through that verification process, the Claimant does not need to provide any additional documents. If we are unable to verify, we will issue a notice to Primary Counsel or a pro se Eligible Claimant requesting either: (1) a Birth Certificate issued by a U.S. State or the U.S. Department of State (for persons born abroad to U.S. Citizen parents); (2) a U.S. Passport issued by the U.S. Department of State; (3) a Certificate of Citizenship (for persons born outside U.S. who derived or acquired U.S. Citizenship through a U.S. Citizen parent); or (4) a Naturalization Certificate (for persons who became a U.S. Citizen after 18 years of age through the naturalization process).  

The Allocation Special Master has determined that EPP Claimants will be eligible to apply for some Extraordinary Injury Fund (“EIF”) categories. The Allocation Methodology states that “FEP Registered Claimants may apply to the Extraordinary Injury Fund (“EIF”) for compensation in addition to any settlement amount based on the Claimant’s Final Point Total….The Allocation Special Master will review the EIF claims and allocate the EIF to claims with a small number of objectively verifiable, unique circumstances that are not otherwise covered by the larger Allocation Methodology. Circumstances likely to qualify a Claimant for an EIF supplement include: death documented as being the result of a Qualifying Injury; surgeries documented as being the result of a Qualifying Injury; certain types of permanent impairment documented as being the result of and secondary to a Qualifying Injury (beyond the Qualifying Injury itself); or Claimants whose Points exceeded the Points Cap…The application form, application fee, and terms and conditions related to the EIF will be provided by the Settlement Administrator as soon as possible, which may be after the Final Registration Deadline.” (Allocation Methodology at 17).

The Allocation Special Master already has issued guidance that i) Claimants who died from a Qualifying Injury and ii) Claimant with a new Qualifying Injury first diagnosed after 4/29/2024 (not a worsening case, but a totally new Qualifying Diagnosis) will be eligible for additional consideration from the EIF. These EIF categories will be available to both EPP and FEP Claimants.

Additional EIF categories are still being considered and eligibility terms and conditions will be contained in future guidance.

Additional EIF categories are still being considered and eligibility terms and conditions will be contained in future guidance. The application form, application fee, and terms and conditions related to the EIF will be provided by the Settlement Administrator as soon as possible, which may be after the Final Registration Deadline. Circumstances likely to qualify a Claimant for an EIF supplement include death documented as being the result of a Qualifying Injury; surgeries documented as being the result of a Qualifying Injury; certain types of permanent impairment documented as being the result of and secondary to a Qualifying Injury (beyond the Qualifying Injury itself); or Claimants whose Points exceeded the Points Cap. (Allocation Methodology at page 17).

The Allocation Special Master has determined that FEP and EPP Cancer Claimants who, after 4/29/24, had surgeries, chemotherapy, radiation, feeding tube, tracheotomy, or additional hospitalization (exceeding 3 days) documented as being the result of a Primary or Secondary Qualifying Cancer Injury will be able to make a claim under the EIF. However, if the Claimant does not meet the latency requirements for anything other than Severity Level 1 for their Qualifying Cancer Injury, their EIF award will be significantly reduced.

Similarly, if a FEP or EPP Claimant with a Qualifying Cancer Injury only qualifies for Severity Level 1 due to not meeting the latency requirements for higher Severity Levels for their Cancer Injury, but had surgeries, chemotherapy, radiation, feeding tube, or a tracheotomy prior to 4/29/2024 (which are associated with the higher Severity Levels), they may be able to make a claim under the EIF. Any such award from the EIF would be significantly reduced on account of the Claimant not meeting the latency requirements.

There is no requirement that medical records be certified. Copies are acceptable if the recorded data is contemporaneous with the Claimant’s care. Records downloaded from patient portals can also be used. However, it is important to confirm that these types of records contain the details required by the Allocation Methodology. For instance, the Allocation Methodology may require, depending on the Claimant’s claimed Qualifying Injury and Severity Level, medical records supporting the Claimant’s initial diagnosis of injuries (either before or after first Recalled Device Usage), hospitalization for the Qualifying Diagnosis, lung function tests with specific values, or prescriptions for certain medications, such as oral steroids prescribed to control the Qualifying Diagnosis.

Affidavits alone will not meet the requirements of the Allocation Methodology because the underlying records that form the basis of the opinion or assertion from the affidavit/expert report must also be provided. Also, it is important for Primary Counsel to remember the rule in the Allocation Methodology that no documents or records created after 4/29/24 may be submitted or used.

There is no need to submit records beyond the requirements of the Injury Record Set. Narrow your submissions to ensure we receive a more focused set of records for processing. Additionally, the Methodology requests that you bookmark the FEP Injury Record Set to clearly document the diagnosis of the Qualifying Injury(ies), Severity Level, and all related Adjustment Factors.

The FEP Record Set requirements are limited to (1) records from the prescriber of the Recalled Device; and (2) complete records, beginning at least 6 months prior to the first use of a Recalled Device, from the physician who diagnosed the Qualifying Injury. The extended set of records is primarily requested to evaluate the claim as new onset or worsening under the Allocation Methodology. We do not require complete histories from all of the Claimant’s other healthcare providers, including those involved in Severity Level determinations (see Allocation Methodology at page 8).

The intent of this request is to determine whether the Qualifying Injury developed before or after first use of the Recalled Device.  If the Claimant did not see the doctor who diagnosed their Qualifying Injury prior to using the Recalled Device, they can provide the records that are available from the diagnosing doctor and they can provide records from doctors other than the diagnosing doctor, such as the prescriber of the Recalled Device.

Please see footnote 13 on page 19 of the Allocation Methodology which is intended to address this issue. It reads, "New Clinical Diagnosis of Asthma or RADS can be established through i) a medical record stating such diagnosis; ii) clinical symptoms of intermittent episodes of wheezing and shortness of breath documented through at least two physician visits during the usage of a Recalled Device; iii) a documented trial of albuterol after first usage of a Recalled Device; or iv) FEV1/FVC <70% on pre-bronchodilator studies with at least 12% improvement in FEV1 post-bronchodilator..." As such, if there is no specific Date of Diagnosis included in the medical records provided, the Date of Diagnosis would be considered the earliest recorded date from a treating physician that establishes one of these requirements.

If the initial diagnosis of Asthma or COPD is missing, the only option for the Claimant would be to provide documentation showing that their condition has worsened. In other words, they could not establish New Asthma or COPD as their Qualifying Injury, however, they could possibly establish Worsening Asthma or COPD.

FEV1/FVC ratio should use the absolute value, not the percent predicted. It is in the column with all the other measurements. See the images included in ASM Guidance Memo #3 pertaining to the example below.

On the first image, Pre-Bronchodilator value for FEV1/FVC is 0.52 (52%). The Post-Bronchodilator value is 0.55 (55%). There is no percent predicted listed on the first image. On the second image, Pre-Bronchodilator value for FEV1/FVC is 68.54%. The Post-Bronchodilator value is 74.17%. You would ignore the Pre-Bronchodilator predicted FEV1/FVC of 94% and the Post BD predicted FEV1/FVC of 101%.

This was an oversight and the “or emphysema” should be on the Severity Level chart for Injury Group B.

For it to be a qualifying diagnosis, the Claimant must have pulmonary sarcoidosis at the time of the diagnosis. This could include:

a. A clinical diagnosis of sarcoidosis and an abnormality on Chest CT to indicate pulmonary sarcoidosis (i.e., Hilar adenopathy, interstitial fibrosis, pulmonary fibrosis) at the time of diagnosis.

b. A lung or mediastinal lymph node biopsy with non-caseating granulomas as the original diagnostic test for sarcoidosis.

c. A clinical diagnosis of pulmonary sarcoidosis from medical records and a biopsy positive for sarcoidosis in a non-pulmonary tissue (i.e., skin, non-chest lymph nodes, etc.).

Documentation of authorized prescription refills will not be treated the same as actual documented refills. The prescription records must indicate refills for purposes of establishing a Severity Level (e.g., “use of albuterol once daily (or 5 – 7 canisters in any year after diagnosis...”)).

A lymphoma of sinonasal mucosa would be classified as a Group I Injury– Mucosa Associated Lymphoid Tissue (MALT) of the Air-Pathway Lymphoid Tissue, and sub-classified by severity level as stipulated by stage and latency.

No, an invasive basal cell carcinoma diagnosis within the nostril would not qualify as a sinonasal and/or nasopharynx cancer. Basal cell carcinoma is a type of skin cancer that typically occurs in areas exposed to the sun, such as the face, including the nostrils. Sinonasal and nasopharynx cancers specifically refer to cancers that originate in the nasal cavity, sinuses, or the nasopharynx (the upper part of the throat behind the nose).

“A clinical diagnosis of "lung scarring"” does not automatically count as a Qualifying Injury (QI) of pulmonary fibrosis for the purposes of the CPAP settlement. The settlement program has specific criteria for what constitutes a Qualifying Injury. For pulmonary fibrosis to be considered a QI, it must be diagnosed as one of the following:

     a. Pulmonary Fibrosis/Interstitial Lung Disease

     b. Pulmonary Fibrosis/Usual Interstitial Pneumonitis

     c. Pulmonary Fibrosis/Nonspecific Interstitial Pneumonitis

These specific diagnoses must be documented in the medical records to qualify. Simply having a clinical diagnosis of "lung scarring" without it being explicitly categorized under one of the above conditions would not meet the criteria for a QI of pulmonary fibrosis. Lung scarring can be a very nonspecific (and often clinically insignificant) finding. If the “lung scarring” is significant typically it would have a more specific diagnosis.

The Level 4 criteria are correctly written. Severity Level 3 and 4 require “At least two PFT results showing FEV1/FVC ratio <70% AND FEV1 =80% of predicted (pre-bronchodilator) [Emphasis added]. The difference between 3 and 4 is that to qualify for Severity Level 4, the records also must reflect the additional elements listed that are more stringent that Level 3, such as:

“c) Methacholine Challenge Test (“MCT”) 4-8 mg/ml as determined by the PC20 value in the interpretation section of the MCT report.

OR

d) Use of albuterol >2 days per week but <7 days per week (or 2-4 canisters in any year after diagnosis), established through medical or pharmacy records.”

Level 5 on the other hand requires a different PFT reading than that required for Levels 3

and 4 referenced above. Specifically, Level 5 requires “At least two PFT results showing15: FEV1/FVC ratio <70% AND FEV1 =60% but <80% of predicted (prebronchodilator). (Emphasis added).

No, medical records with a diagnosis of ""Restrictive Lung Disease"" would not be acceptable for a Claimant that selects Lung Obstruction, New Onset as their Qualifying Injury (QI). "Restrictive Lung Disease" and "Lung Obstruction" are distinct categories of lung conditions.

Lung Obstruction typically refers to conditions that obstruct airflow, such as Chronic Obstructive Pulmonary Disease (COPD) or asthma. In contrast, Restrictive Lung Disease refers to conditions that restrict lung expansion, such as pulmonary fibrosis or interstitial lung disease.

For a claim to be valid under the category of Lung Obstruction, New Onset, the medical records must specifically document a diagnosis that falls under obstructive lung diseases. If the claimant otherwise meets the proof requirements under the Allocation Methodology, they will need to ensure that their medical records reflect the appropriate diagnosis for the selected QI.

The Settlement Allocation Methodology specifies that the Methacholine Challenge Test (MCT) must include a PC20 value to be considered acceptable proof of injury for a claim of Asthma. The PC20 value is a standard measure used to determine the concentration of methacholine that causes a 20% decrease in FEV1 (Forced Expiratory Volume in 1 second), which is a key indicator of bronchial hyperreactivity and asthma. (PD20 has not been widely adopted at this time).

If a Claimant’s Methacholine Challenge Test does not include a PC20 value you should try to qualify the Claimant for the applicable Severity Level through other of the available criteria/options.

A Claimant with pre-existing COPD potentially can be diagnosed with and compensated as a new asthma or new bronchitis Qualifying Injury if there is clear medical evidence showing the onset of these conditions after starting the use of the recalled CPAP device. Medical records must clearly document, consistent with the required testing and results for the Severity Level being claimed, the new diagnosis of asthma or bronchitis, including symptoms, diagnostic tests, and treatments that were not present before using the Recalled Device.

Similarly, a user with pre-existing asthma can be diagnosed with and compensated as a new COPD or new bronchitis Qualifying Injury if there is clear medical evidence showing the onset of these conditions after starting the use of the Recalled CPAP Device. Medical records must clearly document, consistent with the required testing and results for the Severity Level being claimed, the new diagnosis of COPD or bronchitis, including symptoms, diagnostic tests, and treatments that were not present before using the Recalled Device.

A death certificate could be used as part of the Injury Record Set to establish the criteria of a “physician diagnosis”, however see all other FAQs regarding the need for complete records for FEP Claimants in particular (wherein records must be complete enough to determine the Qualifying Injury, Severity Level, all Adjustment Factors, and new onset vs worsening). For EPP, Claimants must submit medical records demonstrating the onset (before or after device usage) as well as diagnosis of a Qualifying Injury (see page 4, CPAP Settlement Allocation Methodology).

The recurrence of cancer is not considered a separate Secondary Qualifying Injury for FEP Claimants. Instead, it is treated as part of the same Primary Qualifying Injury. The recurrence of cancer can impact the Severity Level of the Primary Qualifying Injury for some of the Qualifying Cancers. For example, if a Claimant was diagnosed with sinus cancer, went into remission, and then experienced a recurrence of the same type of cancer, this would be considered a continuation of the same Primary Qualifying Injury. The recurrence would be used to determine the Severity Level and the corresponding points for the Primary Qualifying Injury, rather than being treated as a Secondary Qualifying Injury. According to the CPAP Settlement Allocation Methodology, the Severity Level for certain Qualifying Cancers, including sinus cancer, can be increased based on the recurrence of the cancer and the need for additional treatment. This is outlined in the impairment criteria for various cancer Severity Levels (Exhibit 1, CPAP Settlement Allocation Methodology).

No, a diagnosis of "Acute Respiratory Failure with hypoxia" would not suffice for a Qualifying Injury of Acute Respiratory Distress Syndrome (ARDS) under the CPAP Settlement Allocation Methodology, Group E Injuries. [Many diseases can cause Acute Respiratory Failure with Hypoxia]. The Allocation Methodology specifically lists ARDS as a Qualifying Injury and does not include general acute respiratory failure (ARF) (CPAP Settlement Allocation Methodology, page 31).

To qualify for ARDS, the medical records must explicitly state the diagnosis of ARDS. ARDS is a severe form of lung injury. This is why it was its own category. The criteria for ARDS include specific clinical and physician diagnostic features that differentiate it from other forms of acute respiratory failure. Therefore, it is necessary to have a clear and specific diagnosis of ARDS in the medical records to meet the criteria for this Qualifying Injury.

A Claimant can prove asthma or RADS as a Qualifying Injury by submitting contemporaneous records that indicate a clinical diagnosis. As described in Fn. 13 on page 19 of the Allocation Methodology, a clinical diagnosis does not require a physician diagnosis of asthma or RADS but can be established through the symptoms and treatments set forth in Fn. 13. For Injury Group A Severity Levels 2- 6, however, the Claimant must submit a “physician diagnosis” of the Qualifying Injury (Asthma, RAD, or RADS).

And for Group A Severity Levels 3-6, the Claimant must submit BOTH a physician diagnosis of the Qualifying Injury AND one of the treatment courses or diagnostic tests described in the Severity Level. Thus, if a Claimant’s records only establish a new clinical diagnosis of Asthma or RADs based on the criteria in Fn.13, the maximum Severity Level is A1.

Both could qualify under Group A Injuries (“New and Worsening Asthma and Reactive Airway Dysfunction Syndrome (RADS)”). Reactive Airways Disease (RAD) is often used as a pseudonym for asthma. Technically, RAD is a finding on a PFT or suspicion on clinical exam. Asthma is a diagnosis. However, many medical professionals use these terms interchangeably. Reactive Airways Dysfunction Syndrome (RADS) is a different disease in that it is RAD that is caused by an occupational exposure. Basically, a form of Occupational Asthma. This term often gets misused.

Yes, a physician diagnosis of Small Airways Disease, accompanied by documented wheezing or shortness of breath, would count as Bronchiolitis Obliterans (BO) in the Group D Injuries.

Yes, worsening for the EPP may be inferred through medical records showing increased frequency of asthma attacks, higher doses of medication, or additional treatments required to manage the condition. This can include increased use of albuterol or other rescue inhalers, as well as more frequent visits to healthcare providers. For the EPP, the Settlement Administrator will infer worsening if the following criteria are met:

• Albuterol use documented in at least three prescription records, or medical records noting albuterol use, in any given year after first Recalled Device Usage.

• 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.

In those cases, an initial diagnosis date for the respiratory injury is not required; a worsening election can be made based on this medical documentation.

Cardio-Pulmonary Exercise Test (CPET) and METS: The "maximum workload achieved was 4.6 METS" is indeed a measure used in a Cardio-Pulmonary Exercise Test (CPET). According to the Allocation Methodology, a VO2 max of 4.3-5.0 METS is used to determine Severity Level 4 for COPD.

Diffusion Capacity (DLCO): The Diffusion Capacity results (DLCO) measured in mL are different from the METS results in the CPET. DLCO measures the lung's ability to transfer gas from inhaled air to the bloodstream and is used separately to determine Severity Levels for the Group D Injuries (such as Bronchiolitis Obliterans (BO), Pulmonary Fibrosis / Interstitial Lung Disease (ILD), Pulmonary Fibrosis / Usual Interstitial Pneumonitis (UIP), Pulmonary Fibrosis / Nonspecific Interstitial Pneumonitis (NSIP), Pulmonary Sarcoidosis, Acute Interstitial Pneumonitis), but not COPD (Group B Injuries).

No, lung nodules are not considered lung obstruction. Lung nodules are radiographic (x-ray) findings that may or may not indicate disease but are not a qualified diagnosis alone. Lung obstruction is typically established through abnormal pulmonary function testing (PFTs) and is defined by specific criteria such as FEV1/FVC ratios. See CPAP Settlement Allocation Methodology, p. 28 for the diagnostic criteria for Lung Obstruction (new onset – established with abnormal pulmonary function testing).

The CPAP Settlement Allocation Methodology specifically lists "Mucosa Associated Lymphoid Tissue (MALT) of the air-pathway lymphoid tissue" as a Qualifying Cancer Injury. This includes Bronchial/Tracheal-Associated Lymphoid Tissue (BALT) and Nose-Associated Lymphoid Tissue (NALT) (CPAP Settlement Allocation Methodology at page 36). The physician documentation must specifically reference a diagnosis or treatment of a MALT of the Air-Pathway Lymphoid Tissue, BALT or NALT. Sometimes MALT is called extranodal marginal zone lymphoma, and so physician documentation using this terminology also may be acceptable.

For the FEP, the Allocation Methodology requires a) complete records from the prescriber of the Recalled Device and b) complete records beginning at least 6 months prior to the first use of a Recalled Device, from the physician who diagnosed the Qualifying Injury. Records must be dated prior to April 29, 2024. The intent of this requirement is to ensure FEP Claimant records are complete enough to evidence the applicable Qualifying Diagnosis and Impairment Criteria of a Qualifying Injury, Severity Level, all Adjustment Factors, and new onset vs worsening (CPAP Settlement Allocation Methodology at page 8).

The FAQs have addressed the following:

• Complete histories from all the Claimant’s other healthcare providers, including those involved in Severity Level determinations, are not required.

• If the Claimant did not see the doctor who diagnosed their Qualifying Injury prior to using the Recalled Device, they can provide the records that are available from the diagnosing doctor and they can provide records from doctors other than the diagnosing doctor, such as the prescriber of the Recalled Device.

If complete records from the prescriber of the Recalled Device are not available, the records submitted still may be sufficient so long as they cover the 6-month period prior to usage of the Recalled Device and evidence the applicable Qualifying Diagnosis and Impairment Criteria of a Qualifying Injury, Severity Level, all Adjustment Factors, and new onset vs. worsening.

There are dozens of subtypes of Non-Hodgkin Lymphoma (NHL). NHL is not explicitly listed as a Qualifying Cancer in the CPAP Settlement Allocation Methodology nor is it a Qualifying Diagnosis. The Qualifying Cancers listed in the Allocation Methodology include specific diagnoses such as Lung Cancer, Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), Mucosa Associated Lymphoid Tissue (MALT) of the Air-Pathway Lymphoid Tissue (including Bronchial/Tracheal-Associated Lymphoid Tissue (BALT) and Nose-Associated Lymphoid Tissue (NALT) and various cancers of the thyroid, oropharynx, nasal cavity/sinus, nasopharynx, esophagus, oral cavity, salivary glands, larynx, and hypopharynx.

If you have a clinical diagnosis of Pulmonary Fibrosis without any additional information specifying the sub-type, you can still mark it as a Group D injury on the registration form. According to the Settlement Methodology, Pulmonary Fibrosis is listed under Group D Injuries, which includes:

1. Pulmonary Fibrosis/Interstitial Lung Disease (ILD)

2. Pulmonary Fibrosis/Usual Interstitial Pneumonitis (UIP)

3. Pulmonary Fibrosis/Nonspecific Interstitial Pneumonitis (NSIP)

Regarding subtypes, it is preferable to have one of the more specific categories but that may not always occur as most Claimants will not get a lung biopsy and may not ever receive a more specific diagnosis other than Pulmonary Fibrosis. However, since all these sub-types of Pulmonary Fibrosis have the same point value in the Allocation Methodology, it does not matter which specific sub-type you mark if the information is not available. You can mark it as Pulmonary Fibrosis under Group D injuries.

The medical record diagnosis of Chronic Bronchitis is sufficient to meet the Group C level 1 requirement.

To qualify for Severity Level 2 for Bronchiectasis, the records must show either hospitalization for bronchiectasis exacerbation or pneumonia, or prescriptions for 2 or more courses of oral antibiotics for bronchiectasis exacerbation or pneumonia documented in the medical or pharmacy records more than one year after the initiation of the device. If your client was prescribed 2 different oral antibiotics on the same day, it would generally be considered as one course of treatment rather than two separate courses. The intent is to show multiple instances of treatment over time, indicating ongoing or recurrent issues rather than a single treatment event.

"Advanced stage" is often a surrogate for stage III/IV disease. For a claimant diagnosed with "advanced laryngeal cancer" who underwent both chemotherapy and radiation, but whose records do not specify a stage, you can refer to the impairment criteria for Group O Injuries – Larynx and Hypopharynx Cancers. According to the CPAP Settlement Allocation Methodology, Severity Level 4 for Group O Injuries requires:

• Stage III documented in the medical records, OR

• Stage I-II with multiple modality treatment (meaning at least two of the following treatment types: surgery AND/OR radiation therapy AND/OR chemotherapy)

Since your client underwent both chemotherapy and radiation, which qualifies as multiple modality treatment, they could be placed in Severity Level 4, even though the specific stage is not documented in the records. This is because the criteria allow for multiple modality treatment to qualify for Severity Level 4 in the absence of specific staging information.

To establish Severity Level 3 for a new asthma diagnosis, the criteria include a physician diagnosis of new asthma or RADS and either PFT results showing specific values or the use of albuterol established through medical or pharmacy records. However, since the albuterol usage occurred before the official diagnosis of asthma in 2023, it would not count towards establishing the severity level. The albuterol usage must be documented after the diagnosis to meet the criteria for Severity Level 3.

Acute Promyelocytic Leukemia (APL) qualifies under the settlement program because it is a subtype of Acute Myeloid Leukemia (AML) which is a Qualifying Injury.

Chronic Lymphocytic Leukemia (CLL) does not qualify under the settlement program. The settlement program specifically lists Chronic Myeloid Leukemia (CML) as a Qualifying Injury, and CLL is a different type of leukemia.

Yes, it is completely appropriate to include data prior to formal diagnosis because the work up of the symptoms lead to the diagnosis. The onset would be the day of presentation for evaluation.

For a Category 3 case under the CPAP Settlement, all documentation must be dated prior to February 20, 2025, to be considered. This includes the results of any diagnostic tests such as biopsies. Therefore, if the biopsy was performed on 2/19/25 but the results came in on 2/21/25, the results dated after 2/20/25 would not be considered valid for the purposes of the settlement [CPAP Extraordinary Injury Fund_20250220_Final.pdf] 1. Perhaps there is more information in the pre 2/20/25 record set that could be used to establish the cancer diagnosis?  

If the Pulmonary Function Test (PFT) in the medical records does not have labels indicating whether the values are pre or post bronchodilator, the PFT cannot be considered. The Allocation Methodology requires specific criteria to be met, including clear identification of pre and post bronchodilator values to determine the severity level of the injury. Without these labels, the PFT results do not provide the necessary information to accurately assess the impairment criteria.

For example, the Allocation Methodology specifies that certain severity levels require PFT results showing specific values pre-bronchodilator or post-bronchodilator [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1. Therefore, a PFT without these labels would not meet the required criteria.

For the CPAP settlement, it is important to establish that the Qualifying Injury is related to the use of the Recalled Device. However, the methodology does not explicitly require that you confirm the Qualifying Injury had no alternative cause. Instead, the focus is on demonstrating that the injury meets the criteria outlined in the settlement methodology.

For Bronchiectasis, the key requirement is the identification of bronchiectasis on a Chest CT scan [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1. If the medical records clearly document bronchiectasis and meet the impairment criteria, the cause (such as COVID-19) does not necessarily preclude the injury from being considered a Qualifying Injury.

Similarly, for Worsening COPD, the records must indicate worsening COPD after the use of the Recalled Device [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1. The medication given to treat the lungs should be attributed to the COPD if the treatment records suggest that the treatment is linked to the Qualifying Diagnosis. The Settlement Administrator will assume all treatments are related unless there is a specific reason that attributes the usage to a non-Qualifying Diagnosis [CPAP FAQ 2-11-2025.pdf] 2.

In summary, while it is not required to confirm that there is no alternative cause, it is essential to ensure that the injury meets the criteria specified in the settlement methodology and that the treatment records support the Qualifying Diagnosis.

References:

- CPAP Settlement Allocation Methodology [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1

- CPAP FAQ [CPAP FAQ 2-11-2025.pdf]

For FEP Claimants, the criteria for establishing Worsening Asthma or COPD are indeed different from those for EPP Claimants. According to the CPAP Settlement Allocation Methodology, to qualify for Worsening Asthma or COPD under the FEP, a Claimant must have a pre-existing diagnosis before using the Recalled Device, with documented progression of the disease after starting the use of the device [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1.

To establish a pre-existing diagnosis for FEP Claimants, the medical records must show that the Claimant was diagnosed with asthma or COPD before they began using the Recalled Device. This means that there must be documentation from a healthcare provider indicating the diagnosis prior to the first use of the device. The records should also demonstrate that the condition worsened after the Claimant started using the Recalled Device.

For Severity Level 1, the records must indicate worsening asthma or COPD, similar to the EPP requirement for "worsening" [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1. However, the FEP does not allow for the same flexibility as the EPP in terms of using criteria like albuterol use or increased frequency of medical visits to establish worsening without an initial diagnosis date. The initial diagnosis date is required to confirm that the condition existed before the use of the Recalled Device and that it worsened afterward.

1. Nebulizer Treatment:

- The prescription in Exhibit A for Albuterol Sulfate (2.5 mg/3 mL) 0.083% Nebulizer treatment every four to six hours for cough/wheeze would qualify as daily albuterol use. This is because the treatment is prescribed to be used multiple times a day, indicating regular and consistent use.

2. Inhaler Use:

- The prescription in Exhibit B for Ventolin HFA 108 (90 Base) MCG/ACT Inhalation Aerosol Solution (Albuterol Sulfate) 2 puffs every 4 hours as needed would be considered "use as needed." This means the frequency of use is not fixed and depends on the Claimant's symptoms. To determine if this qualifies as daily use, you would need to search the medical records for additional references that indicate how often the Claimant actually used the inhaler. If the records show that the Claimant used the inhaler daily, it could then be considered daily use.

3. Searching Medical Records:

- You should search the medical records for additional references to how often the Claimant was using the inhaler prescribed "as needed." Look for notes from healthcare providers, refill records, or any other documentation that indicates the frequency of use. This will help establish whether the "as needed" prescription translates to daily use in practice.

According to the CPAP Settlement Allocation Methodology, the use of albuterol must be documented through medical or pharmacy records to establish the frequency of use. Specifically, the methodology states that "use of albuterol once daily (or 5-7 canisters in any year after diagnosis)" must be established through medical or pharmacy records [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1.

In summary:

- The nebulizer treatment qualifies as daily albuterol use.

- The inhaler prescribed "as needed" requires further investigation in the medical records to determine if it qualifies as daily use.

- Additional references in the medical records should be searched to confirm the actual frequency of inhaler use.

References:

- CPAP Settlement Allocation Methodology [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1

If the medical records confirm a diagnosis of Bronchiectasis but do not mention a Chest CT, you cannot confirm the injury based on the Allocation Methodology. The diagnostic criteria specifically require Bronchiectasis to be identified on a Chest CT. You would need to obtain medical records that include the Chest CT results to confirm the injury.

Based on the guidance provided, if a claimant is diagnosed with "advanced laryngeal cancer" and has undergone both chemotherapy and radiation, but the records do not specify a stage, you can refer to the impairment criteria for Group O Injuries – Larynx and Hypopharynx Cancers. According to the CPAP Settlement Allocation Methodology, "advanced stage" is often considered a surrogate for stage III/IV disease.

For Group O Injuries, Severity Level 4 requires either:

- Stage III documented in the medical records, OR

- Stage I-II with multiple modality treatment (meaning at least two of the following treatment types: surgery AND/OR radiation therapy AND/OR chemotherapy) [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1.

Since the claimant underwent both chemotherapy and radiation, which qualifies as multiple modality treatment, they could be placed in Severity Level 4, even though the specific stage is not documented in the records. This is because the criteria allow for multiple modality treatment to qualify for Severity Level 4 in the absence of specific staging information.

Therefore, you should default to Severity Level 4 based on the multiple modality treatment criteria [CPAP Settlement Allocation Methodology_Rev0815.pdf] 

In the context of the CPAP settlement, if a Claimant is diagnosed with cancer and the clinician decides to monitor without treatment, a subsequent diagnosis of the same condition can count as a recurrence. However, the medical records must clearly document that the cancer has returned or worsened.

If the word "recurrent" is not present in the diagnosis, you will need to provide proof that the cancer went into remission and then returned. This can be established through medical records showing the initial diagnosis, a period of remission, and then a subsequent diagnosis indicating the cancer has returned. The Settlement Administrator will determine the earliest date of cancer recurrence and assume that any related treatments after that date are linked, which allows the Claimant to be placed in the Severity Level 5 category for these cancers [CPAP FAQ_20241111_FInal.pdf] 1.

Salvage treatment is relevant for confirming cancer recurrence for the specific cancer types mentioned in the footnotes of the CPAP Settlement Allocation Methodology. The term "salvage treatment" refers to additional treatment required after the initial treatment has failed or the cancer has returned. This is specifically mentioned for certain cancer types, such as Lung Cancer, Oropharynx Cancer, Sinonasal and Nasopharynx Cancers, Oral Cavity and Salivary Cancers, and Larynx and Hypopharynx Cancers  [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1.

For these cancer types, the recurrence must be documented and require salvage treatment, which can include radiation, surgery, and/or chemotherapy. This documentation is necessary to determine the Severity Level and corresponding points for the Primary Qualifying Injury [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1.It may be relevant to proving recurrence for other types of cancer, however, the Settlement Administrator will need to review such documentation to establish that there was a period of remission, and then a subsequent diagnosis indicating the cancer has returned.

No, biopsies do not count as surgical treatment for Qualifying Cancer Injuries. Further, biopsies are specifically excluded from being considered as surgeries related to treatment for purposes of the Extraordinary Injury Fund (EIF) Category 2 [CPAP Extraordinary Injury Fund_20250220_Final.pdf] 1.

When interpreting Pulmonary Function Tests (PFTs) for the CPAP settlement, it is important to ensure that the required values are clearly documented. If the PFT does not have a clear FEV1/FVC ratio, it may not be usable for determining the severity level of the injury.

For the Methacholine Challenge Test (MCT), the Settlement Allocation Methodology specifies that the PC20 value must be included in the interpretation section of the MCT report to be considered acceptable proof of injury for a claim of asthma. The PC20 value is a standard measure used to determine the concentration of methacholine that causes a 20% decrease in FEV1, which is a key indicator of bronchial hyperreactivity and asthma [CPAP FAQ_20241111_FInal.pdf] 1.

If the PFT does not have the necessary labels or values, it cannot be used to establish the impairment criteria. In such cases, you should look for other medical records or tests that clearly document the required values.

Compliance can be proven by a combination of the Usage Record Set and the Injury Record Set. You need to establish the Claimant’s first usage and show that the Claimant used the device for at least one year to obtain the Proof of Compliance Adjustment in the FEP. The Usage Record Set, which includes the types of proof listed below, does not require complete sets of DME records.

(1) Contemporaneous records reflecting use (e.g., references in medical or insurance records indicating the patient is using a Recalled Device or Care Orchestrator Data from a Recalled Device);

(2) Proof of purchase (receipt, prescription, insurance records, etc.);

(3) Photographic evidence showing the serial number and manufacture date of the device;

(4) Proof of participation and registration for the Philips Respironics Recall Program; and

(5) Recall Program data provided to the Settlement Administrator by Philips Respironics, which may establish recorded usage for some Claimants.

You can prove the Claimant still used the device at least one year after the established start date by providing, for example: (1) a contemporaneous medical record with the Injury Record Set that states the Claimant is using their CPAP device; (2) compliance reports from a DME or insurer; (3) documentation from DreamMapper/CareOrchestrator showing the Claimant was using the device; or (4) documentation showing that the Claimant was servicing the device (e.g., replacing CPAP water tanks or humidifiers).

The text which says “because her diagnosis occurred 5 years after her first use” contains a typo. It should say 2 years. The full text in the example correctly states “Her diagnosis of COPD occurred two years after her first use of the device . . .” We have made that correction in the Allocation Methodology and reposted the corrected version to the Portal.

The Claimant is first placed into the Injury Group and Severity Level for which they qualify. Once they are placed in that Group and Severity Level, then the latency adjustments listed on page 10-11 may also apply (except for Group A and E). So, for a Lung Cancer Claimant who only qualifies for Severity Level 1 because they do not have 5 years or more of Latency necessary for Severity Levels 2 through 5, they may still receive a 10% Adjustment to their Severity Level 1 Points if they have between 3 and 5 years of Latency (consistent with the chart on Page 10-11).

The Claimant must provide records reflecting medical care (such as diagnosis records, treatment records or other exams) that were created at the time that such medical care was given. Those must reference that the Claimant has never been a tobacco user or vaping product user or that they are a former user of such products. They should be two distinct records from two distinct visits. It is not necessary that they be from the same provider.

For EPP, the photographic evidence with a manufacture date and serial number satisfies the Proof of Use criteria (“Recorded Usage”) without any other documentation. The claimed date of first use in the Registration Form must be after the manufacture date. EPP Claimants must submit medical records demonstrating the onset or diagnosis of a Qualifying Injury after the date of first use (see page 4, CPAP Settlement Allocation Methodology).

For FEP, Claimants also can establish Recorded Usage with photographic evidence of the CPAP with a manufacture date and serial number. For FEP, however, the Settlement Administrator will use the first record that references use of CPAP to establish the first date of use. In this regard, it is highly recommended that you identify an accurate reference to first usage in medical records and/or obtain additional information from the DME retailer or wholesaler (or insurance records perhaps) to demonstrate when the Claimant first received the device to establish as accurate as possible date of first usage. Without that level of detail, we cannot apply the FEP Adjustment Factors that require a precise usage start date (such as age, compliance, latency).

The Settlement Administrator will use the first medical record that references use of CPAP to establish the first date of use. We highly recommend, however, that you identify an accurate reference to first usage in medical records and/or obtain additional information from the DME retailer or wholesaler (or insurance records perhaps) to demonstrate when the Claimant first received the device to establish as accurate as possible date of first usage. Without that level of detail, we cannot apply the FEP Adjustment Factors that require a precise usage start date (such as age, compliance, latency).

The first documentation that references worsening which is post-dated from the usage start date will be the date utilized to establish the onset age of worsening Asthma or COPD.

For purposes of establishing the first date of usage of a Recalled Device, general mentions of CPAP treatment or use within records are acceptable. For example, if you have a photo of a Claimant’s device with the serial number, you may use general or unspecified mentions of CPAP usage in records (i.e., mentions of CPAP usage without specifying the name of the Recalled Device), provided they follow the manufacture date, to confirm the initial usage date. Likewise, unspecified mentions in records are acceptable for establishing the usage period needed for the Compliance Adjustment.

For purposes of the Compliance Adjustment, the Settlement Administrator will accept a string of records (that continue for at least one year after a record establishing a product start date) which reference that the Claimant has been prescribed and/or utilizing a CPAP as proof of compliance. However, there must not be any documents within that string that indicate non-compliance or intermittent use.

Care Orchestrator data is sufficient to establish Recorded Usage and the dates for the Proof of Compliance Adjustment Factor. When the Care Orchestrator start date or end date is the most beneficial to your client, you may elect to use that date. If there is an acceptable alternative record that is more favorable to your client, you may use that instead of the Care Orchestrator dates.

The shipping confirmation receipt which contains the serial number of the recalled device is adequate proof of the date of first usage. This is consistent with previous guidance that states: The Settlement Administrator will use the first medical record that references use of CPAP to establish the first date of use. We highly recommend, however, that you identify an accurate reference to first usage in medical records and/or obtain additional information from the DME retailer or wholesaler (or insurance records perhaps) to demonstrate when the Claimant first received the device to establish as accurate as possible date of first usage.

To count inpatient days, use the midnight-to-midnight method when a day begins at midnight and ends 24 hours later. A part of any day, including the admission day, counts as a full day. The day of admission counts as day one, regardless of what time the Claimant is admitted as an inpatient. At midnight or 12:01 a.m., day two begins.

For EPP, the photographic evidence with a manufacture date and serial number, and evidence of participation in the Recall Program satisfies the Proof of Use criteria (“Recorded Usage”) without any other documentation. The claimed date of first use in the Registration Form must be after the manufacture date. EPP Claimants must submit medical records demonstrating the onset or diagnosis of a Qualifying Injury after the date of first use (see page 4, CPAP Settlement Allocation Methodology).

If an FEP Claimant submits photographic evidence with a manufacture date and serial number (or evidence of participation in the Recall Program) to establish Proof of Use, they also must establish a first date of use of CPAP for purposes of the Adjustment Factors and certain Severity Levels. [It is unlikely that FEP Claimants only would have photographic evidence or Recall Program data for their Proof of Use since FEP Injury Record Sets must contain complete records from the prescriber of the Recalled Device which should establish the Proof of Use through medical records].

The Settlement Administrator will use the first record that references use of CPAP to establish the first date of use. In this regard, it is highly recommended that you identify an accurate reference to first usage in medical records and/or obtain additional information from the DME retailer or wholesaler (or insurance records perhaps) to demonstrate when the Claimant first received the device to establish as accurate as possible date of first usage. Without that level of detail, we cannot apply the FEP Adjustment Factors that require a precise usage start date (such as age, compliance, latency).

For EPP, they would be considered Recorded Use. For FEP, see response to the previous FAQ. The Settlement Administrator will use the first record that references use of CPAP to establish the first date of use.

If the Claimant registered for the Philips Recall Program, they should have a serial number. When submitting Recall Program registration screen shots as proof of participation and registration in the Philips Recall Program, counsel should provide the serial number where possible (either in the screen shot or entered in the optional field in the Settlement Administrator’s settlement program Registration portal). The screen shots must demonstrate that the Claimant registered in the Philips Recall Program, such as a screen shot of the email the Claimant received upon completing Recall Program registration which contains the Recall Program registration confirmation code. The Settlement Administrator may contact counsel if they have any questions regarding the confirmation code.

If the Claimant cannot locate the email they received upon completing registration which contains the confirmation code, Counsel may go to the Recall home page (https://www.usa.philips.com/healthcare/e/sleep/communications/src-update) and reenter the serial number and take a screen shot that shows that the serial number already has been registered and they can submit that screen shot with an affidavit stating that 1) the serial number is the true serial number of the Claimant’s recalled device, 2) already was registered in the Recall Program as indicated by the screen shot being provided, and 3) the Claimant can no longer locate the confirmation code.

Yes, if a contemporaneous record refers to one of the product names listed in the MSA, the record satisfies the Allocation Methodology’s requirement for Recorded Usage. Where possible, a serial number should still be provided to assist the Settlement Administrator in confirming that the product was a Recalled Device.

Photographic evidence submitted to establish Recorded Usage must clearly indicate the manufacture date and serial number of the Recalled Device. The receipts for parts could help establish the Compliance Adjustment Factor throughout the course of a year, but not Recorded Usage nor a usage start date.

Yes, there is a Reconsideration process for EIF (Extraordinary Injury Fund) claims. The Allocation Methodology specifies that the Reconsideration Process for the EIF will be detailed when the application procedures for the EIF are provided by the Settlement Administrator [CPAP Settlement Allocation Methodology_Rev0815.pdf] 1. This means that the specific details and steps for requesting reconsideration of an EIF claim will be outlined in the materials provided by the Settlement Administrator at a later date.

For now, if you have any questions or need further clarification, it is best to contact the Settlement Administrator directly.

For purposes of EIF Category 2(f), "Distant" Metastasis refers to the spread of cancer from the primary site to distant organs or tissues that are not directly connected to the primary tumor. This typically includes metastasis to organs such as the liver, lungs, bones, or brain. The specific criteria and definitions for "Distant" Metastasis are detailed in the CPAP Settlement Allocation Methodology.

Under EIF Category 2(g), "palliative care" refers to care that is specifically aimed at providing relief from the symptoms and stress of a serious illness. The goal of palliative care is to improve the quality of life for both the patient and the family. This type of care can be provided alongside curative treatment and is not limited to end-of-life care.

There is a distinction between "entering palliative care" and the intent of treatment being "palliative." "Entering palliative care" typically means that the patient has been formally admitted to a palliative care program, which may involve a specialized team of doctors, nurses, and other specialists who work together to provide an extra layer of support. This is often documented in medical records as a specific transition to palliative care services.

On the other hand, the intent of treatment being "palliative" with the goal of improving symptoms and prolonging life refers to the approach or philosophy of care rather than a formal admission to a palliative care program. This can include treatments aimed at symptom management and improving the patient's quality of life, even if they are not formally in a palliative care program.

For the purposes of EIF Category 2(g), documentation should clearly indicate that the patient has entered a palliative care program or is receiving palliative care services as defined above [CPAP Extraordinary Injury Fund_20250220_Final.pdf] 1

A new Qualifying Injury first diagnosed after 4/29/2024 (not a worsening case, but a totally new Qualifying Diagnosis), may be submitted into the EIF fund. So, for instance, a Claimant registers as COPD and has records of that diagnosis which predate 4/29/2024 and then is diagnosed with a Qualifying Cancer after 4/29/2024 but before 1/31/2025. That Claimant will be able to submit the cancer claim into the EIF for separate consideration.

Claims for Claimants who died from a Qualifying Injury will be eligible for additional consideration from the Extraordinary Injury Fund ("EIF"). The application requirements and categories for the EIF will be published in a separate EIF Methodology.

The Allocation Special Master has determined that EPP Claimants will be eligible to apply for some Extraordinary Injury Fund (“EIF”) categories. The Allocation Methodology states that “FEP Registered Claimants may apply to the Extraordinary Injury Fund (“EIF”) for compensation in addition to any settlement amount based on the Claimant’s Final Point Total….The Allocation Special Master will review the EIF claims and allocate the EIF to claims with a small number of objectively verifiable, unique circumstances that are not otherwise covered by the larger Allocation Methodology. Circumstances likely to qualify a Claimant for an EIF supplement include: death documented as being the result of a Qualifying Injury; surgeries documented as being the result of a Qualifying Injury; certain types of permanent impairment documented as being the result of and secondary to a Qualifying Injury (beyond the Qualifying Injury itself); or Claimants whose Points exceeded the Points Cap…The application form, application fee, and terms and conditions related to the EIF will be provided by the Settlement Administrator as soon as possible, which may be after the Final Registration Deadline.” (Allocation Methodology at 17).

The Allocation Special Master already has issued guidance that i) Claimants who died from a Qualifying Injury and ii) Claimant with a new Qualifying Injury first diagnosed after 4/29/2024 (not a worsening case, but a totally new Qualifying Diagnosis) will be eligible for additional consideration from the EIF. These EIF categories will be available to both EPP and FEP Claimants. Additional EIF categories are still being considered and eligibility terms and conditions will be contained in future guidance.

Additional EIF categories are still being considered and eligibility terms and conditions will be contained in future guidance. The application form, application fee, and terms and conditions related to the EIF will be provided by the Settlement Administrator as soon as possible, which may be after the Final Registration Deadline. Circumstances likely to qualify a Claimant for an EIF supplement include death documented as being the result of a Qualifying Injury; surgeries documented as being the result of a Qualifying Injury; certain types of permanent impairment documented as being the result of and secondary to a Qualifying Injury (beyond the Qualifying Injury itself); or Claimants whose Points exceeded the Points Cap. (Allocation Methodology at page 17).

The Allocation Special Master has determined that FEP and EPP Cancer Claimants who, after 4/29/24, had surgeries, chemotherapy, radiation, feeding tube, tracheotomy, or additional hospitalization (exceeding 3 days) documented as being the result of a Primary or Secondary Qualifying Cancer Injury will be able to make a claim under the EIF. However, if the Claimant does not meet the latency requirements for anything other than Severity Level 1 for their Qualifying Cancer Injury, their EIF award will be significantly reduced.

Similarly, if a FEP or EPP Claimant with a Qualifying Cancer Injury only qualifies for Severity Level 1 due to not meeting the latency requirements for higher Severity Levels for their Cancer Injury, but had surgeries, chemotherapy, radiation, feeding tube, or a tracheotomy prior to 4/29/2024 (which are associated with the higher Severity Levels), they may be able to make a claim under the EIF. Any such award from the EIF would be significantly reduced on account of the Claimant not meeting the latency requirements.

No, biopsies do not count as surgical treatment for Qualifying Cancer Injuries. Further, biopsies are specifically excluded from being considered as surgeries related to treatment for purposes of the Extraordinary Injury Fund (EIF) Category 2 [CPAP Extraordinary Injury Fund_20250220_Final.pdf] 1

Any Eligible Claimant who wishes to participate in the Settlement Program must provide a complete and signed Release. If a Claimant’s spouse filed a lawsuit or the Claimant otherwise has a filed lawsuit that names additional plaintiffs or asserts loss of consortium claims, those Derivative Claimants are also required to sign a Release. 

This occurs after the Program has made any Award payment to the Claimant. The filing of the Stipulation of Dismissal has no effect on any claims by the Claimant in the Program, including any claim for an Extraordinary Injury Fund Award.

For Claimants who elect to participate in the Expedited Payment Program, the Allocation Methodology explains the criteria for receiving a $5,000 - $10,000 Settlement Award. The Settlement Administrator will issue you a Notice with the assigned settlement award value.

For Claimants electing to participate in the Full Evaluation Program, the Settlement Administrator will issue you a Notice with the assigned Points value for any Eligible Claimant. After all claims are reviewed and determined, a final Point Dollar Value will be calculated, and a Notice of Award Determination issued to Primary Counsel (or to pro se Claimants) will explain details of the final payment amount associated with the Award.

For represented Claimants, the Settlement Administrator will send your Notice of Award Determination and your Award payment to your Primary Counsel. They will provide you a disbursement statement listing fees and costs and they will handle paying you. For pro se Claimants, you may select your method of payment at the time you accept your Notice. There are a variety of options for you to be paid in the format most convenient to you and your finances including ACH, Check, Venmo, and PayPal.

No. Taxes are not withheld from Settlement Awards. The Settlement Administrator and the Parties do not provide tax, legal, or accounting advice. This is not intended to provide, and should not be relied on for, tax, legal, or accounting advice. You should consult with your own tax, legal, and accounting advisors related to your Settlement Payment.  

Common Benefit Fees reimburse Participating Counsel for the work performed and expenses incurred for the benefit of all plaintiffs. Examples of common benefit work product include pre-trial matters, discovery, trial preparation, potential settlement process, and all other work that advances this litigation to conclusion. Common Benefit Fund payments are subject to the procedures put in place by the MDL Court.

In connection with any payments to Claimants, the Settlement Administrator shall withhold and hold back on a per-Registered-Claimant basis the Common Benefit Assessment as set forth in the MDL Court’s Orders in place now or issued in the future.

The Court entered PTO #24 on 8/29/22 about Common Benefit Assessments, which provided: The assessment shall be ten percent (10%), with eight percent (8%) allocated for common benefit fees and two percent (2%) allocated for common benefit expenses.

On March 14, 2025, the Philips Defendants must pay $1.05 billion into the Settlement Fund. No further funding obligation exists under the Settlement or the Program.

Expedited Payment Program Awards will be paid on a rolling basis to Eligible Claimants after the Settlement Fund is funded. For Full Evaluation Program Claimants, because Settlement Awards are based on assigned Point Values for Eligible Claimants, we cannot pay Settlement Awards until the Allocation Settlement Master completes all Reconsideration requests and can calculate the final Point Dollar Value. After the Point Dollar Value is known, we can issue final determination notices to those Claimants who received Points and then pay those Awards.

When you receive an award through the Philips Respironics Personal Injury Settlement Program (“Award”), your healthcare insurer(s) may pursue reimbursement from your Award for the amount the insurer paid for your CPAP injury-related medical care. This reimbursement amount is known as a Medical Lien. Both government healthcare programs and private health insurance plans may seek Medical Liens against your Award. Generally, you are obligated to pay Medical Liens from your Award based on federal law for government healthcare programs or based on the terms of your private healthcare insurance plan(s). If Medical Liens are not properly resolved, the health plan could stop paying for your medical bills or providing you with other benefits, or it could result in penalties and/or interest payments. For purposes of your CPAP Award, Medical Liens can only exist where a healthcare insurer paid for treatment of your CPAP-related injuries.

Under the Master Settlement Agreement, the court-appointed Lien Administrator (“LA”) is responsible for identifying and resolving most Medical Liens. The Plaintiffs’ Negotiating Counsel has retained Wolf Global Compliance LLC to act as the LA for CPAP personal injury awards.

For purposes of grouping Medical Liens for Philips Respironics personal injury awards, there are three categories of healthcare insurers for whom the LA may identify and/or resolve Medical Liens:

Category 1 Insurers include:

• Traditional Medicare (Part A and Part B);

• Medicaid (ID Order state of residence);

• Veterans Health Administration;

• CHAMPVA;

• TRICARE; and

• Medicare Advantage (Part C) plans, Medicaid MCOs, employer-based healthcare plans, and private healthcare plans that are participating in the CPAP PI Private Lien Resolution Program (“PLRP”). A complete list of PLRP-participating insurers will be posted on the Settlement Portal after it is finalized. See additional FAQs for a provisional list of participating insurers that is subject to change based on finalization of the PLRP Agreement.

The LA will automatically identify and resolve Medical Liens for Category 1 Insurers. Therefore, self-reporting of Category 1 Insurers is not necessary and may result in confusion or duplication. See additional FAQs for details on Category 1 Insurers.

Category 2 Insurers include:

• Non-state of residence Medicaid agencies; and

• Indian Health Services.

You must identify these insurers on the Lien Disclosure Form in your Registration Packet for them to be considered Category 2 Insurers. If you do not do so, these insurers will be considered Category 3 Insurers and you will be responsible for resolution and reimbursement of any Medical Liens they assert.

The LA will identify and resolve Medical Liens for Category 2 Insurers. See additional FAQs for details on Category 2 Insurers.

Category 3 Insurers include all healthcare insurers not covered by Category 1 and Category 2. The LA will not identify Category 3 Insurers and will not resolve Medical Liens for Category 3 Insurers. You are solely responsible for resolution and reimbursement of Medical Liens asserted by Category 3 Insurers.

Identification Process: The Lien Administrator (“LA”) will affirmatively obtain information from all Category 1 Insurers to determine whether you are or were entitled to or enrolled in one or more such healthcare programs or plans. If you are not or were not entitled or enrolled under a Category 1 Insurer, you will be released from any potential liability to such Insurer and the LA will release the associated lien gate. If you are identified as entitled to or enrolled under a Category 1 Insurer, the LA will work with the applicable Insurer to determine whether a Medical Lien exists. The LA will perform this function for all claimants regardless of what is identified on their Lien Disclosure Forms.

Resolution Process: If a Medical Lien from a Category 1 Insurer exists, the LA will audit the Medical Lien to ensure the expenditures are associated CPAP injury-related care, dispute unrelated medical expenditures, negotiate a reduction of the Medical Lien, ensure adherence to lien caps in place and/or exemptions for awards $10,000 or less (if applicable), and pay the final Medical Lien from your Award. You can view all available Medical Lien resolution information by accessing the “Medical Lien Status – Claimant” report on the Settlement Portal. Your attorney will have access to the Settlement Portal and can provide you with this information.

Payment Process: Medical Lien payments for Category 1 Insurers will be made before or concurrent to payment of your Award to your attorney. After payment of any Medical Liens, you will be able to access full records of such Medical Liens. This will include healthcare plan entitlement information, CPAP injury-related care expenditure details, and the Medical Lien repayment amount. Administrative expenses associated with the resolution of Medical Liens will be deducted from your Award consistent with terms approved by the Plaintiffs’ Negotiating Counsel.

Additional Details for Medicare Part A and/or Part B Beneficiaries: If you are or were entitled to Medicare Part A and/or Part B, you may be included in the Global Resolution the LA is pursuing directly with the Centers for Medicare and Medicaid Services (“CMS”) for the purpose of satisfying and discharging Medicare’s past and future claims against Philips Respironics personal injury awards. The Global Resolution will satisfy and discharge Medicare’s claims by determining fixed repayment values, based on Medicare-entitled claimants’ respective approved injury level(s) and enrollment profiles, and then reimbursing CMS in accordance with such fixed repayment values. The Global Resolution will also avoid the time and administrative costs associated with CMS’ traditional, expenditure-based Medicare Secondary Payer recovery process, which involves opening individual cases with CMS for all Medicare beneficiaries receiving personal injury awards, auditing lists of Medicare’s payments, and determining CMS’ final repayment amounts on a claimant-by-claimant basis.

Additional Details for the Private Lien Resolution Program (“PLRP”): The LA will reach agreements to identify and resolve Medical Liens asserted by participating Medicare Part C, Medicaid MCOs, employer-based health insurance plans and private health insurance plans under a set of uniform features, such as predictive timelines, claims filtering for CPAP injury-related care, lien offsets to account for your attorney fees, and percentage caps to ensure your Medical Lien does not exceed a set percentage of gross award value. This arrangement is known as the PLRP. The LA will post a list of PLRP-participating insurers to the Settlement Portal after it is finalized. See additional FAQs for a provisional list of participating insurers that is subject to change based on finalization of the PLRP Agreement.

To conduct the PLRP, the LA will share necessary information directly with participating plans, as well as recovery contractors working on their behalf, including but not limited to The Rawlings Group, Equian LLC, Optum Inc., Carelon, Hill Hill Carter, and Crowell & Moring LLP.

Identification Process: The Lien Administrator (“LA”) will review all self-reported Insurer information provided on claimants’ Lien Disclosure Forms and determine whether these Insurers meet the definition of Category 1, Category 2, or Category 3 for purposes of identifying potential Medical Liens. The LA will notify your attorney if the reported Insurer is Category 1 and being affirmatively addressed or if the reported Insurer is Category 3 and requires attention. If the Insurer is Category 2, the LA will follow the steps below.

Resolution Process: Provided that you identify your Category 2 Insurer on your Lien Disclosure Form, the Lien Administrator (“LA”) will engage the identified Category 2 Insurer and will satisfy any applicable Medical Liens. You can view all available Medical Lien resolution information by accessing the “Medical Lien Status – Claimant” report on the Settlement Portal. Your attorney will have access to the Settlement Portal and can provide you with this information.

You are responsible for identifying any Category 2 Insurers and it is important that you accurately do so. Any Category 2 Insurer that you do not identify on your Lien Disclosure Form will be treated as a Category 3 Insurer. You are responsible for any Medical Liens asserted by a Category 3 Insurer.

Medical Lien Payment: Medical Lien payments for Category 2 Insurers will be made before or concurrent to payment of your Award to your attorney. After payment of any Medical Liens, you will be able to access full records of such Medical Liens. This will include repayment details, and the Medical Lien repayment amount (if any). Administrative expenses associated with the resolution of Medical Liens will be deducted from your Award consistent with terms approved by the Plaintiffs’ Negotiating Counsel.

Resolution Process: You are responsible for Medical Liens asserted by healthcare insurers other than those included in Category 1 or Category 2. The Lien Administrator will have no information on such potential Medical Liens and will be unable to identify or resolve them. For these Medical Liens, you can work with your attorney, contact your healthcare insurer, or consult your health plan documents to review reimbursement obligation information.

Medical Lien Payment: You are solely responsible for payment of Medical Liens asserted by Category 3 Insurers. No funds will be withheld from your Award for such Medical Liens.

The list of participating insurers is below. Contact the Lien Administrator at LienAdministrator@RespironicsPISettlement.com if you have any questions as to your Insurer's participation in the PLRP.

All PLRP-Participating Plans:

1. Absolute Total Care – Healthy Connections Medicaid

2. AchievaMed (SynerMed)

3. Advanced Medical Management

4. Aetna

5. Allied Benefit Systems (Cigna)

6. Allied Phys IPA

7. AltaMed

8. Altius Health Administration (Coventry)

9. America's 1st Choice of South Carolina

10. AmeriGroup

11. Anthem Insurance Companies

12. Anthem Southeast

13. Anthem Workers’ Compensation

14. Arizona Complete Health

15. Arkansas Total Care

16. BCC Partnership Plan

17. Blue Cross Blue Shield

18. Blue Cross Blue Shield AL

19. Blue Cross Blue Shield Alliance Choice

20. Blue Cross Blue Shield AR

21. Blue Cross Blue Shield AZ

22. Blue Cross Blue Shield California

23. Blue Cross Blue Shield Colorado

24. Blue Cross Blue Shield Connecticut

25. Blue Cross Blue Shield Empire New York

26. Blue Cross Blue Shield Florida

27. Blue Cross Blue Shield Georgia

28. Blue Cross Blue Shield Idaho

29. Blue Cross Blue Shield Illinois

30. Blue Cross Blue Shield Indiana

31. Blue Cross Blue Shield Kansas City

32. Blue Cross Blue Shield Kentucky

33. Blue Cross Blue Shield LA

34. Blue Cross Blue Shield Lumenos

35. Blue Cross Blue Shield MA

36. Blue Cross Blue Shield Maine

37. Blue Cross Blue Shield Michigan

38. Blue Cross Blue Shield Missouri

39. Blue Cross Blue Shield MN

40. Blue Cross Blue Shield MS

41. Blue Cross Blue Shield NC

42. Blue Cross Blue Shield ND

43. Blue Cross Blue Shield Nevada

44. Blue Cross Blue Shield New Hampshire

45. Blue Cross Blue Shield Ohio

46. Blue Cross Blue Shield RI

47. Blue Cross Blue Shield SC

48. Blue Cross Blue Shield TN

49. Blue Cross Blue Shield Virginia

50. Blue Cross Blue Shield VT

51. Blue Cross Blue Shield Wisconsin

52. Blue Cross Life and Health Insurance Company

53. Blue Cross Prudent Buyer

54. Bravo Health (Cigna)

55. Cambia

56. Capital BlueCross

57. Carefirst

58. CareMore Health Plan

59. CareSource

60. Centene Corporation

61. Cigna

62. Claim Management Services

63. Community Insurance Company

64. Community Care Health Plan of Louisiana

65. Community Care Health Plan of Nevada

66. Compcare Health Services Insurance Corporation

67. Concordia Health Plan (Cigna)

68. Conifer

69. Coordinated Care

70. Coventry Health

71. Dignity

72. Elevance (Anthem, Amerigroup)

73. Emblem

74. Empire HealthChoice

75. EPIC Mgmt

76. Excellus (Lifetime)

77. Exxon Mobil Med Plan Aetna POS II (Aetna)

78. First Health Coventry Health Care (Coventry)

79. Freedom Health

80. GEHA

81. Great West Healthcare (Cigna)

82. HAP (Health Alliance Plan / HFHS)

83. Harmony Health Plan

84. Harvard Pilgrim (Point32Health)

85. HCSC

86. Health America (Coventry)

87. Health Assurance (Coventry)

88. Health Net Commercial Insurance

89. Health Source MSO

90. HealthCare USA (Coventry)

91. Healthfirst

92. HealthKeepers

93. HealthLink

94. Healthpartners

95. HealthSpring

96. HealthSun Health Plans

97. Healthy Alliance Life Insurance Company

98. Highmark

99. HMO Colorado

100. HMO Missouri

101. HMSA

102. Humana

103. Illinicare Health

104. IND Keystone Flexible Choice

105. Independence Blue Cross (IBX)

106. Independent Health

107. Iowa Total Care

108. Johns Hopkins

109. Kaiser

110. Kaiser Foundation Health Plan (Northern California Region)

111. Kaiser Foundation Health Plan (Southern California Region)

112. Kaiser Foundation Health Plan of Colorado

113. Kaiser Foundation Health Plan of Georgia

114. Kaiser Foundation Health Plan of Hawaii

115. Kaiser Foundation Health Plan of the Mid-Atlantic States

116. Kaiser Foundation Health Plan of the Northwest

117. L.A. Care

118. Louisiana Healthcare Connections

119. Magnolia Health Plan

120. Maine Partners Health Plan

121. Matthew Thornton Health Plan

122. Meridian Health Plan

123. MeridianHealth of Illinois

124. MeridianHealth of Michigan

125. Meritage

126. MHS Health Wisconsin

127. MissouriCare (MO HealthNet)

128. MMO

129. MMOH - Med Mutual Ohio

130. Molina

131. Monticello Service Agency

132. MVP

133. Nebraska Total Care

134. NH Healthy Families

135. NJ Familycare

136. North Carolina State Health Plan

137. Ohana Health Plan

138. Optimum Healthcare

139. Passport

140. Peach State Health Plan

141. Peninsula Health Care

142. PersonalCare Insurance (Coventry)

143. Physicians Healthways

144. Preferred Health Systems (Coventry)

145. Preferred One

146. Premera

147. Priority Health Care

148. RightChoice Insurance Company

149. Rocky Mountain Hospital and Medical Service

150. Sagamore Health Network (CIGNA)

151. Sanford Health

152. SCAN

153. SilverSummit Healthplan

154. Simply Healthcare Plans

155. Starbridge (Cigna)

156. Staywell

157. Sunflower Health Plan

158. Sunshine Health Plan

159. Superior Health Plan

160. Teamsters Benefit Trust

161. Torrance Hospital IPA (THIPA)

162. Trillium Community Health Plan

163. Triple-S Salud (Blue Cross Blue Shield PR)

164. Tufts (Point32Health)

165. UniCare

166. UniCare Health Insurance Company of the Midwest

167. UniCare Health Plan of West Virginia

168. UniCare Hlth Plans of TX

169. UniCare Life & Health

170. UniCare Nations Services

171. United Health Care

172. Verizon

173. VIVA

174. WellCare

175. WellCare of Kentucky

176. WellCare of Nebraska

177. WellCare of North Carolina

178. WellCare of South Carolina

179. Wellmark

180. Western Sky Community Care

181. Windsor

If the healthcare insurer that sent the letter is a Category 1 Insurer or an identified Category 2 Insurer as defined in the FAQs above, do not respond to the letter directly. Your attempts to resolve the Medical Lien could cause confusion, duplication, or delays in the recovery process and/or payment of your Award. Instead, immediately send a complete copy of the correspondence to your attorney who will ensure the Lien Administrator (“LA”) receives it. If you are not represented by an attorney, send a complete copy to the LA by email to LienAdministrator@RespironicsPISettlement.com. In either case, the LA will work directly with the Category 1 Insurer or identified Category 2 Insurer to address the Medical Lien.

If the healthcare insurer that sent the letter is a Category 3 Insurer as defined in the FAQs above, you should work with your attorney or contact the healthcare insurer directly. You are responsible for Medical Liens asserted by Category 3 Insurers.

To continue receiving uninterrupted Medicaid benefits after accepting an Award, you must continue to meet Medicaid’s asset and/or income requirements for your Medicaid benefits. Whether receiving an Award will push you above any applicable asset and/or income limits depends on the type of Medicaid benefit plan you have and your asset and/or income levels before and after the Award. This must be analyzed on an individual basis. The Lien Administrator cannot know what impact this Award will have on your Medicaid eligibility. If you have any questions, discuss them with your Medicaid enrollment broker, case worker, or seek professional advice on preservation of benefits.

If the LA is unable to resolve any Medical Liens asserted by a Category 1 Insurer or a Category 2 Insurer, you will be notified, and such Medical Liens will become your sole responsibility to resolve. If you have questions about whether you must resolve a specific Medical Lien, contact your attorney.

The LA will neither identify nor resolve Medical Liens asserted by a Category 3 Insurer. These Medical Liens are your sole responsibility.

A Reserve Amount is a portion of your Award that the Claims Administrator holds for Medical Lien obligations that are not yet determined or finalized. A Reserve Amount does not mean that there is a Medical Lien. It is an amount held in place until the Lien Administrator identifies and resolves any applicable Medical Liens. The Claims Administrator will use the Reserve Amount to pay Medical Lien and will release any excess to you thereafter.

If a Medical Lien exceeds a Reserve Amount, we will inform you and your attorney (if you are represented) of the balance owed to the healthcare insurer, which you must pay from your Award.

As described in Section B of the Lien Disclosure and Authorization Form (“Form”) in your Registration Packet, the purpose of the Form is to obtain information on healthcare insurers who paid for CPAP injury-related care so that the LA can address Medical Liens. Each section of the Form contains specific instructions which you should read closely. Section I of the Form contains an Authorization for use and sharing of your information to allow for the identification and resolution of any Medical Liens, as well as for other purposes described in Section I of the Form.

If you are represented by an attorney, contact them to answer your questions on Medical Liens. Your attorney has access to Medical Lien reports and can contact the Lien Administrator (LienAdministrator@RespironicsPISettlement.com), if needed.

(a) Bankruptcy Cases Reported on the Registration Form: The Registration Form asks Claimants to indicate whether a Bankruptcy action is currently pending in which he or she is seeking Bankruptcy protection and to resolve any issues arising from the Bankruptcy before any Settlement Payment may be made to such Claimant. The Registration Form asks whether the Claimant declared or sought Bankruptcy protection at any time since the date he or she began use of a Recalled Device or whether a Bankruptcy action is currently pending. The Registration Form allows Claimants to provide information about the Bankruptcy, including the Bankruptcy Court/Jurisdiction, Case Number, and Date Filed.

(b) Bankruptcy Cases Not Reported on the Registration Form: We will not conduct any independent research to discover whether a Claimant has a current Bankruptcy action pending. If a Claimants or their Primary Counsel alerts us before we have issued paying to the Claimant to a Bankruptcy action not disclosed on a Registration Form, the Claimant becomes subject to this Procedure.

Federal Bankruptcy Code 11 U.S.C. §543 prohibits us from making a payment to a Claimant when we have notice of their Bankruptcy case.

Whether Bankruptcy Documents are required depends on the Bankruptcy case chapter, case commencement date, case disposition, disposition date and the date a Claimant contacted an attorney regarding his or her use of a Recalled Device and subsequent Qualifying Injury.

(a) Bankruptcy Documents are not required for:

     (1) Any Claimant whose Bankruptcy case was dismissed or closed before the date he or she contacted an attorney regarding his or her use of a Recalled Device and subsequent Qualifying Injury; or

     (2) Any Claimant whose Chapter 12 or 13 Bankruptcy case is closed if: (a) it was filed before and still pending as of the date he or she contacted an attorney regarding use of a Recalled Device and subsequent Qualifying Injury; and (b) it has been more than 180 days since the entry of an order of confirmation.

(b) Bankruptcy Documents are required for:

     (1) All Claimants with open bankruptcy cases;

     (2) Any Claimant whose Chapter 7 Bankruptcy case is closed but was filed on or after the date he or she contacted an attorney regarding his or her use a Recalled Device and subsequent Qualifying Injury;

     (3) Any Claimant whose Chapter 12 or 13 Bankruptcy case is closed if: (a) it was filed before and still pending as of the date he or she contacted an attorney regarding his or her use a Recalled Device and subsequent Qualifying Injury; and (b) it has been less than 180 days since the entry of an order of confirmation.

If Bankruptcy Documents are required, the Eligible Claimants must provide documents from either:

(a) An Order from the Bankruptcy Court that:

     (1) Approves the settlement and payment of the Settlement Award;

     (2) Identifies the person of persons to whom the payment is to be made; or

(b) An Order from the Bankruptcy Court, letter or email from the Bankruptcy Trustee, or other official Bankruptcy documents showing that:

     (1) The Settlement Award was not property of the Bankruptcy estate;

     (2) The Settlement Award was disclaimed, abandoned, or exempted in the Bankruptcy proceeding; or

     (3) The Bankruptcy Trustee does not intend to pursue the Settlement Award as a potential asset of the Bankruptcy estate.

Even if your Bankruptcy case is closed, your Settlement Award may still be property of the bankruptcy estate under §541 of the United States Bankruptcy Code if the Bankruptcy was filed:

(a) On or after the date you contacted an attorney about your use of a Recalled Device and subsequent Qualifying Injury; or

(b) Before the date you contacted an attorney about your use of a Recalled Device and subsequent Qualifying Injury but remained open and pending as of that date.

You must identify a Legal Representative for all Claimants who are currently deceased, incapacitated, or a minor. You can add a Representative Claimant through the Personal Representative Information for Deceased, Minor, or Incapacitated Eligible Claimants in the Registration Form on your Portal.

You should leave the deceased Claimant’s name on the Eligible Claimants List (ECL) and in the Claimant’s file in the MDL Centrality portal, but the contact information (phone number, email address, mailing address) should be updated to the Representative’s contact information on the ECL and in the Claimant’s file.

The Legal Representative (or the Primary Counsel for the Deceased Eligible Claimant, if represented) must upload proof of the Representative Claimant's appointment under applicable state law. Section 3.5 of the MSA provides that for any Deceased Eligible Claimant receiving a Settlement Award of $75,000 or more, the Registration Forms must be signed by a representative for the Deceased Eligible Claimant appointed in accordance with applicable state law. For any Deceased Eligible Claimant receiving less than $75,000, the Registration Forms may be signed by all beneficiaries identified in a Family Settlement Affidavit or the representative who satisfies the small estate administration rules consistent with applicable state law. The following documents listed in either (a) or (b) below may be provided in support of the Legal Representative’s authority:

(a) Documented Appointment. A copy of a court order, letters of administration (including small estate administration), letters testamentary, or other official document issued by a court or other appropriate official and appointing or identifying the Legal Representative as the personal representative, administrator, small estate administrator, executor, or other position with authority to act under applicable state law on behalf of the Deceased or Deceased’s estate.

(b) Additional Representative Claimant Proof Documents. Other forms of proof or authority may be accepted only if approved by the Defendants or as authorized by the Court.

(c) The Settlement Program’s Family Settlement Affidavit if the gross settlement award is less than $75,000.

No. Under Section 3.5 of the MSA, for purposes of completing a Registration Form, a beneficiary, recognized under state law, of the deceased Eligible Claimant may initially execute the Registration Form and Release. An appropriate beneficiary of the deceased Eligible Claimant under applicable state law can sign the materials for the Registration Packet. They do not have to be appointed by a probate court to do that. If an individual is already appointed by a probate court, then that appointed individual should sign the Registration Packet.

What additional proof of representative capacity will be necessary will depend on the award allocation to that deceased Eligible Claimant. Under Section 3.5, if the allocation to the deceased Eligible Claimant is $75,000 or more, the Release will not be effective until executed by a representative for the deceased Eligible Claimant appointed in accordance with applicable state law. For any deceased Eligible Claimant who will receive less than $75,000, the Release will be effective if signed by all beneficiaries identified in a family settlement affidavit or the representative satisfies the small estate administration rules consistent with applicable state law.

No Claimant may be paid until a valid and effective Release has been completed and signed. This will be addressed at the payment stage and not as part of Registration.

If a deceased, incapacitated, or minor Claimant has more than one Legal Representative with equal authority to execute documents on their behalf, any one of those Representatives may sign the Release. In cases where the Eligible Claimant is Deceased and their allocation is less than $75,000, all beneficiaries identified in a family settlement statement or a Legal Representative who satisfies the small estate administration rules consistent with applicable state law may execute the Release.  

Payments made to Claimants with a Legal Representative will be issued to the Legal Representative (or the Legal Representative's attorney, if represented) after we determine sufficient documents supporting the Legal Representative’s authority to act on behalf of the deceased, incapacitated, or minor Claimant.  

An Eligible Claimant who is unable to understand or communicate information necessary to make decisions about his or her of physical health, safety, or property management and as a result has been found by a court or agency with proper jurisdiction as legally incompetent or incapacitated. We presume all Eligible Claimants have legal capacity unless we are presented with a copy of a judicial or agency determination of legal incapacity. Incarceration alone is not sufficient proof of an Eligible Claimant's incompetency or incapacity.

The Legal Representative (or the Primary Counsel for an Incapacitated Eligible Claimant, if represented) must upload to the Settlement Administrator one of the following as proof of their appointment under applicable state law:

(a) Local Court Appointment. A copy of a court order, letters of guardianship, letters of conservatorship, certification, or other official document issued by a court or other appropriate official and appointing the Legal Representative as guardian, conservator, curator, personal representative, or other position with authority to act on behalf of the Incompetent Eligible Claimant.

(b) Durable Power of Attorney. A copy of a properly executed and still-in-effect durable or springing power of attorney naming the Legal Representative as the agent for an Incapacitated Eligible Claimant. A retainer agreement with a lawyer or law firm is not sufficient for a Legal Representative to establish such authority.

(c) Additional Representative Claimant Proof Documents. Other forms of proof or authority may be accepted only if approved by the Parties or as authorized by the Court.