FDA addresses further promoting telecommunications technology in Medicare

Oct. 30, 2020

In an effort to promote efficiencies, a finalized rule, beginning January 1, 2021, brings permanent changes to the home health regulations, as originally outlined in the March 2020 “Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency” Interim Final Rule with Comment (85 FR 19230), stated guidance from the U.S. Food and Drug Administration (FDA). 

Home health agencies (HHAs) can utilize telecommunications technologies in providing care to beneficiaries under the Medicare home health benefit, as long as any provision of remote patient monitoring or other services furnished via a telecommunications system or audio-only technology are included on the plan of care. The use of such telecommunications technology or audio-only technology must be tied to the patient-specific needs as identified in the comprehensive assessment. The Centers for Medicare & Medicaid Services (CMS) will not require a description of how such technology will help to achieve the goals outlined on the plan of care; rather, documentation in the medical record should explain how such services will help facilitate treatment outcomes.

The use of technology may not substitute for an in-person home visit that is ordered on the plan of care and cannot be considered a visit for the purpose of patient eligibility or payment. However, the use of technology may result in efficiencies in the furnishing of home health care, which may result in changes to the frequencies and types of in-person visits as ordered on the plan of care. This rule also expands the definition of telecommunications technology, in addition to remote patient monitoring, that HHAs are allowed to report as allowable administrative costs on the HHA cost report. These finalized policies will ensure patient access to the latest technology and give HHAs predictability that they can continue to use telecommunications technology as part of patient care.

Updates to the Home Health Prospective Payment System rates for CY 2021

This rule finalizes routine, statutorily required updates to the home health payment rates for CY 2021. CMS estimates that Medicare payments to HHAs in CY 2021 will increase in the aggregate by 1.9 percent, or $390 million, based on the finalized policies. This increase reflects the effects of the 2.0 percent home health payment update percentage ($410 million increase) and a 0.1 percent decrease in payments due to reductions in the rural add-on percentages mandated by the Bipartisan Budget Act of 2018 for CY 2021 ($20 million decrease). This rule also updates the home health wage index including the adoption of revised OMB statistical area delineations and limiting any decreases in a geographic area’s wage index value to no more than five percent in CY 2021.

Updates to the Home Infusion Therapy Benefit for CY 2021

This rule implements Medicare enrollment policies for qualified home infusion therapy suppliers, updates the CY 2021 home infusion therapy services payment rates using the CY 2021 Physician Fee Schedule amounts, and excludes home infusion therapy services from home health services as required by law.

Home Health Value Based Purchasing Model

This rule finalizes, without modification, policies that appeared in the May 8, 2020 Federal Register (85 FR 27553), as required by law. The FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act (42 U.S.C. 247d(a)(2)).

Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled "Process for Making Available Guidance Documents Related to Coronavirus Disease 2019," this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.

FDA has the guidance