Preparing for the End of the Public Health Emergency

Changes to PHE waivers for Medicare and Medicaid beneficiary patients YouCompli

Changes to PHE waivers and recommendations for hospitals. Compliance must assist and advise on policy, process, contractual, and operational changes by May 2023.

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Growth in Telemedicine Could Mean Trouble if You Are Not Careful

We can all agree that 2020 was a year filled with surprises. The emergence of COVID-19 brought restrictions, which made the business of healthcare even more challenging. But then came the saving grace: telemedicine!

Even though telemedicine has been around in some form since the 1900s, its popularity exploded during the midst of the pandemic. With millions of people stuck indoors due to government lockdowns, health care providers turned to telemedicine options to provide desperately needed health care.

According to Doximity, a social media networking service for medical professionals, only 14 percent of Americans utilized telemedicine before the pandemic. But since the outbreak, telemedicine usage skyrocketed by 57 percent. Among patients suffering from chronic conditions, the number of virtual care visits increased by a staggering 77 percent!

The increase in telemedicine accessibility also means healthcare providers can potentially face compliance issue pitfalls, which could land them in trouble with the United States government. Before COVID-19 became a household name, Medicare and Medicaid upheld strict rules regarding payment for telemedicine services. For instance, reimbursement for telemedicine services was limited to patients residing in areas of the country with limited healthcare.In an attempt to slow the spread of COVID-19, government payors loosened these restrictions.

Unfortunately, telehealth services’ widespread use brought an uptick in COVID-19 related scams that specifically target healthcare providers offering this service. Such illegal activity caught the attention of the Department of Justice (D.O.J.).

A primary focus of the D.O.J. is a government agency that mostly focuses on telehealth arrangements that implicate the Anti-Kickback Statute.  The statute forbids transactions designed to corrupt medical judgment by rewarding referrals for Medicaid and Medicare services. In the past year, more than $4.5 billion in false claims were connected to telemedicine. And over 100 healthcare professionals were charged with submitting fraudulent claims to Medicare, Medicaid, and private insurance companies.

New changes to the Stark and Anti-Kickback Statutes that were long in the works took effect on January 19, 2021. The regulation updates are designed to eliminate regulatory and administrative barriers that hindered movement towards a value-based health care system. The updated rules also offer healthcare providers more flexibility to coordinate and improve patient care while maintaining safeguards against overutilization and inappropriate incentives.

The Stark Exceptions finalized three new exceptions for value-based arrangements between healthcare providers and payor systems like Medicaid and Medicare. These exemptions are solely based on the quality of delivered patient care instead of the volume of services.  For example, healthcare providers face at least a 10 percent financial risk for failure to achieve value-based goals. In comparison, the Anti-Kickback Statute requires at least a 5 percent financial risk for value-based arrangements.

Physicians’ practices should express caution when offering telemedicine services to steer clear of trouble with the government. As with traditional in-person healthcare, it’s best to avoid doing business with third-party companies that give money in exchange for referrals.

Here are a few guidelines physicians should consider avoiding getting on the D.O.J.’s naughty list.

  1. Consult with counsel before entering into any outside business relationships.
  2. Establish guidelines for physical examinations and prescribing practices.
  3. Monitor the prescribing habits of their physicians and nurse practitioners.
  4. Adopt data analytic tools to identify any abnormal billing behavior.

Physicians considering telemedicine should also consider the following tips to stay compliant.

Practicing Telemedicine Across State Lines.

Usually, state governments require practicing physicians to conduct telemedicine sessions within the state they are licensed. But in some states, this stipulation is relaxed due to COVID-19 to make healthcare more accessible. But physicians must contact their state’s medical board for updated information concerning this topic.

Informed Consent.

Healthcare providers are still expected to obtain consent before providing telehealth services. Besides requesting written or verbal consent from patients, providers should make patients aware of the risks and benefits of receiving telehealth services.

Use Caution When Prescribing Medication.

Because of COVID-19, the Drug Enforcement Administration (D.E.A.) allows registered practitioners to use prescribed medication to patients via telemedcicine technology. Physicians must adhere to the following conditions:

  • Prescribed medication(s) must be for a legitimate medical purpose.
  • The telehealth session is conducted using a two-way, audio-visual, interactive communication system.
  • The practitioners must practice healthcare within Federal and State law.

Only time will tell whether or not telemedicine will continue to grow in the upcoming months. But doctors should continue to use caution when using this technology to serve the public.

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COVID-19 Testing: New Federal Clarifications for Employers

You’ve probably heard of recent federal legislation affecting insurance coverage for COVID-19 testing and related services, such as the Families First Coronavirus Response (Families First) Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The federal government has taken steps to require certain kinds of insurance plans to provide coverage for testing (and related services) without cost-sharing, prior authorizations, or other medical management requirements.

New Guidance Issued

On June 23, three federal departments — the Department of Health and Human Services (HHS), the Department of the Treasury, and the Department of Labor — issued a second round of guidance on implementing these provisions.

The Centers for Medicare & Medicaid Services (CMS) has published an FAQ specifically related to the Families First Act which contains some useful information related to this guidance. (Click here to read the full document.)

CMS has confirmed that the Families First Act does not require employers and insurers to pay for COVID-19 testing that is not used for diagnostic purposes. This includes back to work purposes or general screening. And there are no exceptions for the uninsured or those receiving Medicaid coverage.

In the case of diagnostic testing, the law allows for quite a broad range of coverage. Tests must be approved by HHS (which includes tests approved by the Food and Drug Administration (FDA) on an emergency or temporary basis). But as long as one of these approved tests is ordered by an attending health care provider, “where medically appropriate for the individual,” then insurers must pay for it. And that’s even if there are multiple tests ordered.

COVID-19 Tests Not Covered

However, for tests that are not for diagnostic purposes, things get more complicated. If employers require their employees to have clean COVID-19 tests before returning to work, there are basically two options, neither of which insurance is required to help with under this legislation:

  1. Pick up the tab for testing themselves, or
  2. Ask employees to either cover it (which can be very expensive) or line up at one of the free public testing sites.

Implications for Compliance

As with most of the regulatory changes related to the pandemic, the devil is in the details here. Staying up to date on the latest guidance and clarification is the only way to be sure that you are providing the correct information to the rest of your organization.

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AHA and CMS to Keep Regulatory Flexibilities in Place

COVID-19 continues to create obstacles and challenges for healthcare compliance professionals. Thriving in this environment means being agile and adaptive.

The AHA’s Requests

Last week, the American Hospital Association (AHA) asked the Centers for Medicare & Medicaid Services (CMS) to keep relaxed regulations in place. Specifically, the AHA is interested in keeping flexibility around telehealth, quality and compliance measures, and bed capacity.

The telehealth changes are ones that have been on the horizon for some time. Essentially, the AHA is asking CMS to continue to allow hospitals to provide a wide range of telehealth services, without limitations as to profession or geographic location. The AHA is also asking for flexibility on billing and payments related to telehealth to be made permanent.
More interestingly, the AHA has also asked that CMS extend regulatory relief related to some quality and patient safety regulations. These include expanding the use of verbal orders, and extending the reuse of PPE.

The AHA has also asked that CMS provide hospitals with a transition period, to allow them to more easily move from pandemic response to ordinary practice. This includes a request for temporary waivers for sanctions and penalties related to HIPAA , and flexibility on audit requirements. And, it includes a request that certain rules and requirements be delayed or suspended.

The Response From CMS

Three days after the AHA released this letter, Michael Caputo, Assistant Secretary for Public Affairs at the Department of Health and Human Services (HHS), tweeted this :

The public health emergency is currently set to expire on July 25. However, as of this writing, HHS hasn’t officially announced how long the extension will be

This means that we don’t yet know what will happen when the emergency finally does end. Will HHS give a transition period, as the AHA has requested? Will HHS continue to allow flexibility about telehealth, which they have previously indicated they would?

Staying up to date on this fluid situation is going to be a key task for compliance in the coming weeks.

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The Results Are In: What the Data Say About the Impact of COVID-19 on Healthcare Compliance

We keep hearing that COVID-19 changed everything, especially in healthcare. But actual data is pretty thin on the ground.

Mostly, we’ve been hearing anecdotes and stories, many of which are striking. The problem with stories is that they can be unique or unusual, and without the context of clear data, we can’t really tell.

Last week, we got some data.

In May, the Society of Corporate Compliance and Ethics (SCCE) and the Health Care Compliance Association (HCCA) surveyed their audiences on the impact of COVID-19 on their organizations and their work. They received 300 responses, have collated the results, and there are some interesting trends. You can read the full survey results here.

Confirming What We Knew

Some trends are unsurprising, and confirm what we already knew. Survey respondents said they had concerns about the increased risk of compliance failures as a result of the pandemic.

  • 77% expected that there would be some increase, or a great increase, in compliance failures.

It’s also unsurprising to see that healthcare saw more of an increase in the number of inquiries being made of the compliance team.

  • 42% reported an increase in healthcare
  • 30% reported an increase outside of healthcare

Given the number of healthcare-related regulatory waivers and temporary changes that have been issued, this makes total sense.

Positively, collaboration with other departments has been largely unaffected or increased during the pandemic. Compliance is still seen as really valuable to the organization as a whole. The numbers range from 83% to 96% of respondents reporting that collaboration has stayed the same or increased (depending on department).

Differences for Healthcare Compliance

The data also show some surprising trends, specifically related to healthcare compliance.

We know that there has been a huge shift to remote work. The surprising aspect is that the shift is very different between healthcare compliance and compliance elsewhere.

  • In healthcare, 60% reported working remotely
  • Outside of healthcare, 84% reported working remotely

This gap is big, and hard to explain. Working in healthcare institutions would, presumably, increase the risk of being exposed to the virus. It would have been reasonable to expect that healthcare institutions would do as much as possible to try to get their non-clinical staff set up to work effectively off-site.

What’s even more surprising is that healthcare professionals are less likely to report that the transition to remote work has gone well.

  • In healthcare, 47% said the transition had gone better than expected
  • Outside of healthcare, 64% said the transition had gone better than expected

The survey doesn’t indicate why this is so. Speculating a little, it could be that the disruption in moving to a remote office, coupled with the sudden influx of regulatory changes, made it more difficult for healthcare compliance professionals to manage their day-to-day work. If this is true, it would also explain why healthcare institutions were less likely to transition compliance professionals to remote work.

There’s another difference between healthcare and other types of organizations, and this suggests things will be difficult for compliance professionals going forward into 2021. In relation to budgets:

  • In healthcare, 40% reported a budget reduction
  • Outside of healthcare, 31% reported a budget reduction

In short, budget reductions are coming to compliance, as they are going to come to other parts of the healthcare system. (If they aren’t already in place.) As COVID-19 related waivers and suspensions start to expire, compliance is going to have to find a way to do more with fewer resources.

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