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Cigna welcomes the opportunity to respond to the Notice of Proposed Rulemaking (NPRM) for the CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Home Infusion Therapy Services Requirements. We appreciate the ongoing work by the
In addition to our comprehensive services as both an insurer and a pharmacy benefit manager, our subsidiary specialty pharmacy, Accredo(R), serves patients with complex and chronic health conditions, including those treatable with home infusion. It is in this context that we provide the following comments on these aspects of the NPRM.
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1. General Comments
Cigna would like additional clarity around the enrollment process and requirements for a "Pharmacy Supplier" using internal or contracted professional nursing services to meet billing requirements for the home infusion therapy (HIT) benefit.
Section 1861(iii)(3)(D)(i) of the Social Security Act (the Act) defines a "qualified home infusion therapy supplier" as a pharmacy, physician, or other provider of services or supplier licensed by the state in which supplies or services are furnished. The provision specifies that qualified HIT suppliers must furnish infusion therapy to individuals with acute or chronic conditions requiring administration of home infusion drugs; ensure the safe and effective provision and administration of HIT on a 7-day-a-week, 24-hour-a-day basis; be accredited by an organization designated by the Secretary of HHS; and meet other such requirements as the Secretary deems appropriate, taking into account the standards of care for HIT established by Medicare Advantage plans under Part C and in the private sector. The supplier may subcontract with a pharmacy, physician, other qualified supplier or provider of medical services, in order to meet these requirements. Provider is defined in section 1861(iii)(3)(A) of the Act as a physician, nurse practitioner, or physician's assistant.
Currently, each of our Accredo(R) specialty pharmacy locations is enrolled as a Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Supplier under application CMS-855-S and has started or completed the process of enrollment under application CMS-855B. Under the proposed rule, "beginning
2. CY 2021 Payments for Home Infusion Therapy Services
HIT eligible drugs:
The proposed rule notes that Hizentra (HCPCS Code J1559), subcutaneous immune globulin (IG), is not included in the definition of home infusion drugs because it is listed on the self-administered drug (SAD) exclusion list by the MACs. Therefore, although HIT services related to the administration of Hizentra are covered under the temporary transitional payment, because it is on a SAD exclusion list, services related to the administration of this biological will not be covered under the benefit in 2021.
We provided feedback on Hizentra in our
According to CMS, as cited and published by
However, historically, CMS has stated that chronic disease treatment with DME-dependent SADs should be excluded from the SAD exclusion list; we note Hizentra fits that description and should therefore be included within the HIT benefit.
Related to covering subcutaneous IG drugs in category 2, we also recommend modifying the definition of "infusion drug administration calendar day" to include days on which HIT services are self-administered by a beneficiary regardless of whether a HIT supplier was physically present in the beneficiary's home.
3. Comments on the
Cigna recognizes the success of the Medicare IVIG Demonstration project and its extension in 2017. Our specialty pharmacy, Accredo(R), has served and will continue to serve beneficiaries enrolled in the project. However, the anticipated expiration on
We recommend extending again, or making permanent the home infusion benefits currently available to beneficiaries using IVIG. Due to the circumstances surrounding the COVID-19 global pandemic, beneficiaries may be unable to find a suitable alternate infusion site, which could interrupt therapy. Additionally, these beneficiaries are in a high-risk population due to both age and compromised immune status, meaning the exposure to an infusion setting may elevate their health risks. As an example, a study from 2017/2 showed that patients who receive IVIG at home had lower rates of pneumonia and bronchitis than those treated in a hospital outpatient infusion center.
The COVID-19 pandemic has also led to reduced plasma collections. According to the
In addition to the health and safety concerns outlined above, removing the ability for patients to receive IVIG infusions in their homes can place other burdens on patients and their families. For example, personal cost, transportation, and time associated with having to travel to a new site are some of the significant burdens patients and their families will face. Additionally, alternative sites could be more costly. A study from 2016/3 noted that home infusion had the same or better quality, higher patient satisfaction, and lower costs as compared to medical setting infusion costs.
Thank you in advance for your consideration of these comments. Cigna would welcome the opportunity to discuss these issues with you in more detail at your convenience.
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The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0077-0002
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