Medicare Compliance & Reimbursement

The 1135 waiver offers temporary relief for providers.

As providers across the nation attempt to rein in the spread of the 2019 novel coronavirus (COVID-19), the feds are offering much needed telehealth flexibilities to help high-risk patients.

First: On March 11, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus pronounced COVID-19 a pandemic. This was quickly followed by the declaration of a national state of emergency on March 13 by President Donald Trump.

Then: On March 17, the Centers for Medicare & Medicaid Services (CMS) significantly expanded its telehealth access policies for beneficiaries. In the wake of the international crisis and in response to the national state of emergency, CMS announced “regulatory flexibilities” in line with the “1135 waiver authority and Coronavirus Preparedness and Response Supplemental Appropriations Act” to circumvent the spread of the virus, give providers more options, and assist vulnerable patients, says a fact sheet on the changes.

“The Trump Administration is taking swift and bold action to give patients greater access to care through telehealth during the COVID-19 outbreak,” said CMS Administrator Seema Verma in a release. “These changes allow seniors to communicate with their doctors without having to travel to a healthcare facility so that they can limit risk of exposure and spread of this virus. Clinicians on the frontlines will now have greater flexibility to safely treat our beneficiaries.”

Reminder: Certain federal healthcare programs’ regulations fall under the Social Security Act (i.e. Medicare, Medicaid, CHIP), and specific things must happen for requirements to be waived with an 1135 waiver. First, the president must declare an emergency under the Stafford or National Emergencies Act and the HHS Secretary must declare a public health emergency (PHE) under Section 319 of the Public Health Service Act. Without the combination of those two things, it’s business as usual.

When Medicare claims and billing requirements impede the increased need for quick and efficient care, the feds generally implement 1135 waivers and increased flexibilities. The circumstances surrounding the onslaught of COVID-19 have caused the feds to ramp up their guidance and assistance, so that infrastructures and the delivery of care remain stable for beneficiaries across the various healthcare programs. Moreover, the 1135 waivers ensure that CMS’ providers and suppliers continue to be reimbursed for their services and products.

Register These 1135 Waiver Changes

If you’re already all-in on virtual care, then you’re ahead of the curve. You may be using telecommunication technology in your organization to care for Medicare beneficiaries now — and that makes understanding the policy changes under the 1135 waiver a little bit easier to address.

Before the feds instituted the waiver, Medicare paid for telehealth services only on a “limited basis.” But the pandemic necessitates regulatory rollbacks and a serious easement of former telehealth coverage rules.

“Traditionally, under the Medicare program, professional telehealth services are restricted by statute to originating site locations, defined generally as healthcare facilities and physician offices, that are located in rural areas or outside of Metropolitan Statistical Areas (MSAs),” explain attorneys Jacob J. Harper, Eric J. Knickrehm, and Scott A. Memmott with international law firm Morgan, Lewis & Bockius LLP in the Health Law Scan blog.

Plus: “Medicare beneficiaries generally would not be allowed to receive telehealth services in their home[s],” Harper, Knickrehm, and Memmott continue in their analysis. The Coronavirus Preparedness and Response Supplemental Appropriations Act (CPRSAA) “waived both of these requirements, enabling Medicare beneficiaries across the country, regardless of urban or rural location, to receive telehealth services, including in their home, from a doctor in a remote location directly through their smart phone or computer.”

Providers Get Enforcement Reprieve With Waivers

New guidance from the HHS Office of Inspector General (OIG) suggests the federal watchdog is easing up on Medicare providers with new telehealth visit flexibilities amid the COVID-19 pandemic, too. Copay waivers would normally fall under the federal Anti-Kickback Statute (AKS) and register as a kickback; plus, waiving fees and cost-sharing could be considered a beneficiary inducement as part of the Civil Monetary Penalty Law (CMPL).

Policy update: OIG will not bring AKS or CMPL enforcement actions against providers who “waive any cost-sharing for telehealth visits during the public health emergency” as long as “all applicable CMS payment and coverage rules are met,” an OIG release says.

See the OIG policy change at https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/factsheet-telehealth-2020.pdf.

Positives: CMS’ telehealth policies are woefully behind those of states and private payers, and the waivers required because of COVID-19 may have positive long-term impacts on future Medicare updates, suggest Harper, Knickrehm, and Memmott. “Although CMS makes a point of noting that this waiver is temporary, if telehealth is successfully furnished to Medicare beneficiaries during the crisis, this may create the momentum necessary to convince Congress to bring the Medicare telehealth benefit into the 21st Century and enact a permanent Medicare telehealth bill in the near future,” they stress.