Eye on Enforcement / Certain Pandemic Telehealth Services Continue While Enforcement Efforts Increase

REGULATORY UPDATE

Certain Pandemic Telehealth Services Continue While Enforcement Efforts Increase

SNAPSHOT

A flurry of government activity surrounding telehealth services surfaced last month, showing signs of continued support. And with it, recognition of associated fraud and quality concerns. 

More recently, Washington leaders are preparing for a post-pandemic phase. Providers will need to monitor the changing telehealth landscape to avoid a misstep. It’s time to plan the wind down of waivered activities implemented during the pandemic in advance of any government deadlines. 

Read on for highlights of the government’s multi-faceted approach.

BEHIND THE HEADLINES

Congress Prepares for the End (Yet Extends Certain Pandemic Waivers)

On March 15, President Biden signed the Consolidated Appropriations Act of 2022 (CAA), which, among other things, extends certain pandemic-era telehealth flexibilities otherwise limited to the duration of the public health emergency (PHE). Congress specifically expanded several key telehealth flexibilities for a period of 151 days (five months) beyond the  end of the emergency declaration recently announced to be July 15, 2022. This includes providing telehealth services at an individual’s home and the use of audio-only technology. 

The CAA also extends the temporary expansion of permissible telehealth providers to occupational therapists, physical therapists, speech language pathologists and audiologists and the permissible delay of in-person visits for mental health patients prior to obtaining telehealth services. 

Additionally, the 151-day extension will apply to prior distant-site flexibilities granted to federally qualified health centers (FQHCs) and rural health clinics. Whether we’ll see statutory or regulatory changes to make these flexibilities permanent is an open question, though the U.S. Department of Health & Human Services (HHS) has signaled a commitment to telehealth while simultaneously studying its flaws and limitations.

In late April, Washington leaders (including Dr. Fauci) began socializing the notion that we’re out of the “pandemic” phase of COVID-19. While the PHE declaration hasn’t officially ended and the CAA’s extensions haven’t yet been triggered, we know two things:

  1. The end of PHE flexibilities may be approaching and legislators realize stakeholders will need to ween from the relaxed rules in their return to normal; and
  2. A 5-month grace period may become the standard to which agencies look as they, too, wind down their temporary pandemic guidance. 
HHS Watchdog Centralizes Telehealth Oversight Work

In early April, the U.S. Department of Health & Human Services Office of the Inspector General (HHS-OIG) announced a new webpage consolidating its work in the telehealth space. It will highlight its oversight work assessing telehealth services, including the impact of various PHE flexibilities, and provide objective findings and recommendations for policymakers and other stakeholders considering changes to telehealth policies. 

OIG asserted, “While the expansion of telehealth has been critical to maintaining beneficiaries’ access to care, it’s important that new policies and technologies with potential to improve care and enhance access achieve these goals and are not compromised by fraud, abuse or misuse.” 

Even so, OIG posted a March report observing telehealth was critical for the “long-term potential of telehealth to increase access to healthcare for beneficiaries.” It highlighted the over 28 million Medicare beneficiaries who used telehealth during the first year of the pandemic — more than two in five beneficiaries. In that same time, beneficiaries used 88 times more telehealth services than in the prior year.

This shift was facilitated, in part, by a series of waivers issued by the Centers for Medicare & Medicaid Services (CMS) and OIG beginning in March 2020. For instance, on the heels of various CMS telehealth waivers, OIG issued a “Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak.” 

OIG subsequently clarified its statement isn’t limited to the services governed by 42 C.F.R. § 410.78 and referred to by CMS as “telehealth visits.” Instead, OIG applied the waiver to a broad category of non-face-to-face services furnished through various modalities, including telehealth visits, virtual check-in services, e-visits, monthly remote care management and monthly remote patient monitoring

In effect, OIG granted a broad — and temporary — beneficiary cost-sharing waiver exception/safe harbor to help providers expand their telehealth offerings and improve beneficiary engagement during the pandemic. Nevertheless, it should end with the expiration of the PHE.

Similarly, OIG has maintained a COVID-19 FAQ feature on its website, issuing enforcement guidance during the pandemic — mimicking miniature advisory opinions of limited duration and scope. 

For example, OIG relaxed certain enforcement priorities, advising that a hospital’s provision of free access to a web-based telehealth platform to independent physicians on its medical staff would present a low risk of fraud and abuse during the pandemic

In light of those flexibilities in coverage for various telehealth and other virtual services payable by federal healthcare programs, OIG signaled mental health or substance use disorder providers could give patients a cell phone, service or data plan (or both) to facilitate telehealth services with a few exceptions and safeguards in mind. These, too, will terminate with the PHE.

Advisory Opinion 22-08: Will OIG Shift COVID-Era Guidance from FAQ to Opinions?

OIG’s FAQ guidance, like its general telehealth flexibilities, is set to expire when the PHE declaration lifts. Whether it will extend these flexibilities beyond the pandemic, or how it may implement any wind-down grace period to allow providers to transition back to pre-pandemic rules, remains to be seen. This could present challenges where beneficiaries and providers alike have grown accustomed to waivers related to telehealth services.

For that reason, parties relying on OIG’s temporary guidance during the PHE may seek advisory opinions to preserve protection for their practices beyond the PHE. In fact, on April 27, OIG approved an arrangement (Advisory Opinion 22-08) that bears many similarities to the aforementioned FAQ involving free telephones to facilitate telehealth services. 

OIG blessed an arrangement for certain existing patients of a requestor (an FQHC) to keep limited-use smartphones loaned to them during the PHE to access telehealth services and to combat social isolation. The loans were made possible through grants received during the PHE, and funded by charities and government programs (such as the Federal Communication Commission’s COVID-19 Telehealth Program), none of whom had any stake in the reimbursable telehealth services provided. Patients were screened to confirm need and to avoid device duplication. Almost all patients with loaner phones fell below 200% of the federal poverty level. 

Patients can keep the smartphone as long as they’ve received at least one service from the FQHC in the prior 24-month period (regardless of whether it was a telehealth service). Though patients are not prohibited from using the smartphones for telemedicine visits with other healthcare providers, its capabilities are limited to the telemedicine application used by the FQHC.

OIG determined the program implicates the Anti-Kickback Statute (AKS) and the beneficiary inducement civil monetary penalties (CMP) provisions. But given the number of safeguards present, it concluded the program was low risk under the AKS, and also satisfied the so-called “promotes access to care” exception to the beneficiary inducements CMP, granting a favorable opinion.

Because many of these details overlap with OIG’s prior guidance, it’s reasonable to conclude the requestor currently relies on OIG’s PHE FAQ flexibilities and had the foresight to prepare for OIG’s termination of waivers and other guidance by requesting an advisory opinion. Of course, advisory opinions are only beneficial to the requestor of the opinion, but they do provide insight into OIG’s thought process. 

Perhaps OIG is signaling that some of its pandemic-era guidance warrants a continuation, or at least a grace period, after the emergency declaration ends. We expect OIG to use its enforcement discretion to target egregious actors during the transition, but providers should monitor the agency’s new telehealth webpages and follow breaking advisory opinions for guidance. Those providers currently relying on agency waivers and flexibilities also should consider an advisory opinion request to secure more permanent relief.   

CMS Begins Terminating Pandemic-Era Waivers, Citing Quality Concerns

Perhaps as an example of how the agencies plan to issue terminations, CMS recently began terminating certain pandemic-related waivers intended to provide healthcare providers with extra flexibilities to respond to the pandemic. For instance, on April 7, 2022, CMS announced abbreviated wind-down periods for two categories of waivers in the long-term care space. It noted,”While the waivers of regulatory requirements have provided flexibility in how nursing homes may operate, they have also removed the minimum standards for quality that help ensure residents’ health and safety are protected.” 

Citing onsite surveys that revealed significant concerns with resident care, CMS concluded waivers contributed to these outcomes and raised other concerns. For example, CMS waived requirements for physicians and practitioners to perform in-person assessments, “which may have prevented these individuals from performing an accurate assessment of the resident’s clinical needs, contributing to depression or pressure ulcers.” Of particular note, CMS believes waivers associated with physician delegation and physician visits, along with staff training and physical safety protocols, negatively affected quality. 

As a result, CMS is ending the specific emergency declaration blanket waivers for SNFs/NFs, inpatient hospices, ICF/IIDs and ESRD facilities (with 30- and 60-day wind-down periods). The termination of these blanket waivers has no effect on other blanket waivers that remain in place, such as those for hospitals and critical access hospitals. But this measure demonstrates CMS is actively evaluating the costs and benefits of various waivers, in particular where relaxed in-person requirements caused a decline in quality. 

This action could signal how CMS will react to other quality concerns associated with pandemic-era telehealth waivers.

GAO is Watching Telehealth Quality Issues

The Government Accountability Office (GAO) recently issued a report recommending CMS assess the effect of increased telehealth use on Medicaid beneficiaries’ quality of care. The report cites the rapid expansion due to pandemic flexibilities has met with some limitations. GAO observed CMS currently doesn’t collect and evaluate the impact of telehealth on the quality of care in these Medicaid programs. It specifically noted the potential for fraud, waste and abuse in the provision of telehealth services. But it recognized “CMS officials said they considered the risk of fraud due to the use of services delivered via telehealth during the pandemic to be minimal in comparison to the health risks of in-person services or foregone care.”

Nonetheless, GAO issued two recommendations to CMS:

  1. to collect and analyze information about the effect that delivering services via telehealth has on the quality of care Medicaid beneficiaries receive, and
  2. determine any next steps based on the results of the analysis. 

CMS neither agreed nor disagreed with these recommendations, so we should monitor legislative priorities in this space.

Recent Telehealth Fraud Settlement Shows DOJ Priorities

The U.S. Department of Justice (DOJ) is stepping up its pandemic-related fraud enforcement efforts, including civil and criminal probes involving telehealth services. Recently, a Florida provider agreed to pay $24.5 million to resolve False Claims Act allegations involving unnecessary medical testing and services. Importantly, the allegations included a scheme to make up for lost revenue from the cancellation of elective procedures in response to COVID emergency orders by increasing evaluation and management telemedicine services provided under pandemic-related flexibilities.

Meanwhile, on April 20, DOJ and OIG announced a Nationwide Coordinated Law Enforcement Action to combat healthcare-related COVID-19 fraud, including a number of new arrests. DOJ specifically highlighted one type of COVID-19 healthcare fraud scheme: parties exploiting policies CMS “put in place to enable increased access to care during the COVID-19 pandemic.” The Justice Department specifically highlighted schemes involving sham telemedicine encounters and others designed to gain access to telehealth patients.  

We can expect DOJ will emphasize enforcement related to OIG and CMS telehealth flexibilities and abuses thereof. Providers should focus on winding down any programs that rely on such flexibilities according to any government-mandated periods, if and when the PHE declaration is terminated.

What You Can Do Now

Congress and HHS leadership signaled their intent to continue the push towards beneficial telehealth services beyond the pandemic. CMS is evaluating quality concerns associated with pandemic waivers, and OIG and DOJ appear active in the enforcement space. While garden-variety telehealth fraud cases emerged early on in the pandemic, we expect to see the government pursue more sophisticated arrangements under the anti-kickback statute and beneficiary inducement laws as telehealth remains prevalent. 

As we see telehealth enforcement increase, many wonder what will happen as the government recalls pandemic-era flexibilities, in particular CMS’ and OIG’s waivers and FAQ guidance. Expect low-hanging fruit to fall first, but now is the time to create a transition plan. 

Providers should consider:

  • Which waivers and guidance they’re relying on today, and how difficult it will be to unwind
    • Consider CMS waivers related to conditions of participation, licensure, record-keeping requirements, EMTALA and the Stark self-referral law.
    • Take a close look at contract obligations created during the pandemic. Are there temporary provisions and addenda that auto-terminate when certain waivers wind down or is manual termination necessary?
    • Examine company policies and procedures related to waivered conduct. Do they expire/revert automatically or must the organization terminate them and issue new guidance? Appropriate messaging to personnel about the return to pre-pandemic rules will be critical.
  • How many programs rely on pandemic cost-sharing waivers and other OIG guidance involving free items and services to beneficiaries?
    • Don’t forget about remote patient monitoring services and beneficiaries’ sudden objection to cost-sharing amounts once COVID waivers are recalled.
  • Consider requesting an OIG or CMS advisory opinion if shifting away from reliance on pandemic flexibilities is too disruptive.

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These materials are for general informational purposes only. These materials do not, and are not intended to, constitute legal or compliance advice, and you should not act or refrain from acting based on any information provided in these materials.Neither Ensemble Health Partners, nor any of its employees, are your lawyers.Please consult with your own legal counsel or compliance professional regarding specific legal or compliance questions you have.