“As healthcare fraud, waste, and abuse continues to emerge, and poses more of a risk to organizational compliance, professionals should become familiar with some of the potential areas of noncompliance associated with telehealth.”Continue reading
“It behooves all healthcare compliance professionals to be aware of the fraud, waste and abuse risks associated with telehealth services. This mode of delivery holds great promise. For it to fulfill that promise, non-compliance needs to be rooted out and corrected.”Continue reading
Illegal beneficiary inducements include: free insulin, deflated Medicare copayment, courtesy adjustments for injections, free glucometers and waived co-paymentsContinue reading
As a compliance officer, it’s time to go back through your compliance documentation over the past two years. How are you going to unwind from these changesContinue reading
How providers stay in compliance as demand for telehealth surges. How healthcare providers are preparing for the regulatory changes that will come with the end of the public health emergency.Continue reading
Featured speakers: Craig Bennett, Vice President and Chief Compliance Officer, Boston Medical Center; Rachel Lerner, Esq., General Counsel & Chief Compliance Officer, Director, Center for the Prevention of Elder Abuse and Neglect, Hebrew SeniorLife; Maria Palumbo, Chief Compliance & Privacy Officer, Lawrence General Hospital. Moderated by Larry Vernaglia
Bennett, Lerner and Palumbo addressed the Massachusetts Health and Hospital Association’s Healthcare Legal Compliance Forum in December 2021. (Read a summary.) This recap of their remarks looks at how their Compliance teams responded to COVID and have continued to partner with their organizations to manage regulatory change. It also looks at regulatory changes they are planning for in 2022. To access the full session recording, please contact the Massachusetts Health and Hospital Association.
Initial COVID response
The panel reflected on their organizations’ initial response to COVID. “All of us had to pivot on a dime,” said Bennett. “We hadn’t had an opportunity to plan for it. Instead, we worked daily that first quarter to make sure we were as compliant as we could possibly be.” He was part of a team that looked at various waivers, platform security, privacy and other issues affected by the public health emergency to provide care safely.
Lerner had a similar experience. “We immediately convened interdisciplinary committee so we could make changes quickly. Telehealth was really new territory for us, and we had to look at our outpatient medical practice, and home- and community-based care,” she said. “Tracking COVID 19 waivers was a team sport between Legal and Compliance. We broke down some silos, and that may be one good lasting benefit of this experience.”
Palumbo and her colleagues focused on creating templates and consistency for documentation to make things as straightforward as possible for clinicians. That included having them track their patient contact time in minutes rather than defaulting to 20-minute increments. “We’re auditing these processes now to be sure we’re prepared when it gets looked at externally.”
Accessibility concerns and solutions
Palumbo illustrated how healthcare organizations had to respond to the specific needs of their communities. “Our population tends not to have computers or printers at home,” she said. It wasn’t enough to deliver COVID test results to the portal, because people needed printed results to return to work or school. Without a printer, they were stuck. “We were like the take-out line at a restaurant – we not only have to contract with the state to provide nine-lane testing, we also have a multiline drive up for picking up your covid test results because people need that hard paper.”
Building a culture of compliance
Bennett reflected on the tremendous amount of change and adaptation healthcare staff managed over the past two years. “I have to commend all hospital staff in being able to pivot and not missing a beat,” he said. His organization paused or reprioritized certain issues, but they maintained a focus on complying with regulations. That meant checking in with people regularly. That helped him assess whether people were getting the support and resources they needed related to their work. He expects to continue looking for ways to support staff. “We’ll continue to try to add flexibility to meet the needs of our staff and the needs of our patients and organization.”
Palumbo, too, is working to meet people where they are at. She recently “camped out in the cafeteria,” she said. “I couldn’t believe the results: About 350 people came to talk to me, including residents, physicians, surgeons, nurses, case managers, and housekeeping staff.” They asked about patient privacy and other compliance issues. “So much came up during COVID but we didn’t stop to work through everything or stop to talk to each other. I’ll try to do that at least once a quarter.”
New compliance issues
Palumbo walked through some upcoming regulatory changes she’s watching. This included the Medicare Final Physician Fee Schedule and noted that the Appropriate Use Criteria changes are delayed until the January first that follows the end of the pandemic. She encouraged everyone to understand the documentation requirements for using nurse practitioners for some portion of care as well as the changes to billing for surgeon and ICU provider time.
New rules also allow audio-only telehealth visits for behavioral health as long as the patient wants it and the physician documents it properly.
Balancing privacy, efficiency, safety, and cybersecurity
Lerner continues to address privacy concerns related to COVID testing and contact tracing. “We were working so hard to limit the spread of the disease in our senior living facilities,” she said. “It was hard to navigate contact tracing and privacy.” Now she is addressing cybersecurity insurance requirements, for her own organization and making sure vendors have sufficient insurance. “Moving to remote workforces and telehealth, the cybersecurity exposure is higher than it’s ever been,” she said. “For instance, people working from home might want to print documents, but we have to keep them from printing PHI at home or mailing things insecurely when someone can’t come pick it up.”
Managing regulatory change
Lerner said she spends a lot of time looking at regulatory changes to understand their implications to her organization. “It can take us a long time to decide ‘does this apply to us?’ And then figure out what to do with it. Then we have to figure out what to do with that information in bits and pieces. It is certainly a complex, ever-changing universe on that front.” She spoke of Compliance’s key role in knitting together all that information to help the organization act on it and integrate it into daily processes.
YouCompli sponsored MHA’s 2021 Healthcare Legal Compliance Forum. We provide a complete solution to help healthcare compliance organizations manage regulatory change. Find out more about YouCompli.
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A good Compliance department doesn’t need to be huge with a lot of people and formal processes,” Callahan said. “A good department is one that has a real effect when they ask leadership to make a change.Continue reading
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.
- Consult with counsel before entering into any outside business relationships.
- Establish guidelines for physical examinations and prescribing practices.
- Monitor the prescribing habits of their physicians and nurse practitioners.
- 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.
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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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:
- Pick up the tab for testing themselves, or
- 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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