CMS Issues Over-the-Counter Coronavirus Testing Guidance

February 07, 2022 - CMS released guidance around the over-the-counter coronavirus testing requirement, providing greater clarity regarding what kinds of direct-to-consumer access mechanisms fall under compliance and answering questions related to testing shortages and fraud.

The guidance explained that the requirement to provide adequate access to over-the-counter coronavirus tests entails establishing an in-person method of receiving the tests and a direct-to-consumer shipping option.

“A direct-to-consumer shipping mechanism is any program that provides direct coverage of OTC COVID-19 tests for participants, beneficiaries, or enrollees without requiring the individual to obtain the test at an in-person location,” the guidance explained.

CMS also outlined what kinds of tests count as over-the-counter tests eligible for coverage. The agency explained that tests that can be self-collected but processed in a separate location do not fall under the over-the-counter coronavirus testing requirement.

CMS emphasized that it sought to provide payers with much flexibility around making over-the-counter testing available to members. 

The agency suggested four ways for payers to offer access to tests, noting that the list was not exhaustive. Payers could set up a telephonic or online direct-to-consumer shipping program, leverage their pharmacy network, work with non-pharmacy retailers, and set up coronavirus testing sites that offer over-the-counter options.

The guidance further elucidated what payers have to achieve to offer adequate access. The agency acknowledged that multiple factors play into adequacy, including pharmacy network utilization among members and payers’ outreach strategies to make members aware of their over-the-counter coronavirus testing options.

Importantly, adequate access does not entail providing coverage for every type of over-the-counter coronavirus test.

One of the primary problems that payers and consumers faced with this rule was that coronavirus tests are limited in supply. An eHealth survey found that almost three out of ten consumers experienced challenges accessing a coronavirus test in the past six months. 

CMS explained that payers would not be penalized for not providing access to over-the-counter coronavirus tests if their supply is limited due to the shortage. Payers who face this scenario can continue restricting their coronavirus testing coverage to $12 per test.

The payer industry’s responsibility is to address over-the-counter coronavirus test reimbursement fraud and abuse. The agency’s guidance provided insight into how payers can fight fraud and abuse, particularly for purchases finalized without a provider’s engagement.

Major payer organizations have responded positively to the agency’s decision to require Medicare to cover at-home coronavirus tests.

“Medicare coverage of over-the-counter COVID tests is a critical step in ensuring timely, equitable and affordable access — no matter where you live, how old you are or whether you have private health insurance. Our seniors and the most vulnerable deserve this important and potentially life-saving benefit,” Ceci Connolly, president and chief executive officer of the Alliance of Community Health Plans (ACHP), said in a statement.

“In the face of significant hurdles with supply issues, the Alliance of Community Health Plans’ members have worked around the clock to implement the initial testing guidance and look forward to additional clarifying details. We appreciate our productive conversations with the Administration that have led to this important improvement in testing guidance.”

 “As Americans continue to come together to fight COVID-19, health insurance providers remain a collaborative partner, taking decisive actions to ensure that everyone has access to the testing, treatment, and vaccines they need,” Matt Eyles, president and chief executive officer of AHIP, added in a statement responding to the CMS Medicare initiative for over-the-counter coronavirus testing coverage. 

“We applaud CMS for launching this new initiative for Medicare coverage of free over-the-counter COVID-19 tests for all seniors and people with disabilities. This is a commendable model and the right path – for Medicare-eligible people and for all Americans – to ensure equitable access, swift treatment, and an effective response to the virus. With effective testing, treatment, and vaccination strategies, we will overcome the COVID-19 crisis.”

The agency has also required commercial payers to provide coverage for at-home coronavirus testing.