Centers for Medicare & Medicaid Services COVID-19 Interim Final Review Response

By Maddie Mason, Senior Associate, Policy

The National Health Council (NHC) submitted comments signed by 26 national patient organizations to the Centers for Medicare and Medicaid Services (CMS) in response to their COVID-19 Interim Final Rule (IFR) that we believe has the capability of maintaining patient health and safety without increasing out-of-pocket costs, and will save lives by enhancing access to care for many Americans if operationalized in an appropriate manner. The COVID-19 IFR would give patients the ability to stay home to receive treatments and services and avoid the risk of a potentially serious COVID-19 exposure while receiving life-saving treatments. In our comments, we focused on three specific areas within the IFR that patients and caregivers identified as the highest priorities during this public health emergency. The following are some of the issues we covered in the comments.

Increased flexibility to enable patients to receive their infused or injected treatments in their homes when safe and appropriate.

Patient populations with chronic conditions are at a heightened risk of developing a serious and life-threatening COVID-19 infection, so it is important for them to minimize the risk of exposure. We are concerned for the well-being of these constituents leaving their homes, even when it is to receive needed medical treatment, so we support the Administration’s steps designed to expand home infusion/injection capacity and enable Medicare beneficiaries to receive needed treatments while complying with recommendations to remain in their homes. To strengthen the COVID-19 IFR, we urged the Agency to:

• Further reinforce that the decision on whether drug administration services should be performed in the home or provider setting should be made at the individual patient level in consultation with the treating clinician;
• Consider additional flexibilities to enable providers to offer this important service in the least burdensome manner possible; and
• Ensure that beneficiaries who receive care in their homes through these increased flexibilities do not incur additional out-of-pocket costs as compared to what their cost-sharing obligations would be in a non-home setting or site of care.

We believe these protections are essential to protect the well-being of patients, access to care, and adherence to prescribed treatments and regimens.

Modified Definition of “homebound” for home health eligibility purposes to include clinician consideration of patient exposure to COVID-19 (or other pathogens).

Our organizations supported the Agency’s clarification of the definition of “homebound” for home health eligibility purposes to include instances of confirmed or suspected COVID-19, and circumstances where leaving the home would be contraindicated due to potential for contracting COVID-19. We agree with the Centers for Disease Control and Prevention’s (CDC’s) guidelines for allowing clinicians to determine when a patient should be considered “confined to the home,” and we urge CMS to streamline provider certifications to allow clinicians to make these homebound status’ for their patients.

Reduced paperwork and other burdens for providers prescribing oxygen and other durable medical equipment (DME) supplies for use in their patient’s homes.

We are appreciative of the steps CMS has taken in the COVID-19 IFR to reduce clinician burdens and restrictions that may be associated with prescribing certain types of DME because the COVID-19 pandemic and public health emergency has the potential to greatly increase demand for in-home oxygen and other supplied covered under the DME benefit. We supported the following provisions:

• Relaxation of the requirement of a face-to-face or in-person encounter to elevate and/or certify a patient’s need for in-home oxygen and other DME and related supplies;
• Non-enforcement of clinical indications for coverage across respiratory, home anticoagulation management, and infusion pumps national and local coverage determinations (NCDs and LCDs) that include, but are not limited to those in the COVID-19 IFR; and
• Flexibility with respect to additional requirements under NCDs and LCDs, such as consultation and supervision requirements.

We are sincerely appreciative of the significant steps CMS has taken in response to the COVID-19 pandemic and are grateful for the opportunity to work with the Agency and hope to continue to work with them on the behalf of patients.

For more information, please read our full comments here. The following 26 organizations joined us in the submission of these comments:

• Alliance for Aging Research
• Alpha-1 Foundation
• ALS Association
• American Association on Health and Disability
• American Autoimmune Related Diseases Association
• American Foundation for Suicide Prevention
• American Kidney Fund
• American Lung Association
• American Thoracic Society
• Cancer Support Community
• Colorectal Cancer Alliance
• COPD Foundation
• Everylife Foundation for Rare Disease
• GBS-CIBD Foundation International
• Lakeshore Foundation
• Lupus Foundation of America
• Mental Health America
• Muscular Dystrophy Association
• National Alliance on Mental Illness
• National Health Council
• National Patient Advocate Foundation
• National Psoriasis Foundation
• Prevent Blindness
• Pulmonary Fibrosis Foundation
• Solve ME/CFS Initiative
• Spina Bifida Association