Health organizations tackle regulatory change at Mass. conference

The Massachusetts Health and Hospital Association recently convened its Healthcare Legal Compliance Forum to update members on key areas of regulatory change, compliance and enforcement in this late COVID era. 

Current and former law enforcement officials, healthcare compliance practitioners, attorneys and consultants gave a broad view of the priorities, challenges and opportunities facing the Compliance profession.  

Federal and State Enforcement Update 

Featured speakers: Toby R. Unger, Chief of Medicaid Fraud Division, Office of the Massachusetts Attorney General; and Patrick Callahan, Healthcare Fraud Unit, US Attorney’s Office. Moderated by David Schumacher, Partner, Hooper, Lundy & Bookman. 

Unger and Callahan noted that the pandemic shifted the makeup of their case load. It reduced the rate of whistleblower and other fraud complaints, and for Unger at least, abuse cases increased.  

They talked about how health organizations can effectively partner with law enforcement. They generally see the best outcomes when Compliance and Legal teams bring issues to them or work quickly with them to find data and resolve issues. 

And they shared their take on effective Compliance functions. 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. They have a voice that gets leadership’s attention, and they can have questionable practices stopped during an investigation. When they ask to press pause, they are listened to.”  

Read More: State and Federal enforcement agencies anticipating more complex investigations as COVID-era practices emerge

Compliance Officer Roundtable  

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 shared their experience over nearly two years of pandemic-influenced healthcare compliance. They talked about how they collaborated to manage regulatory change and reinforce their culture of compliance. They also talked about the regulatory changes they are planning for in 2022.  

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 correctly and then integrate it into daily processes. 

Read More: Compliance officers reflect on COVID pivots and preparing for the end of the public health emergency

Telehealth in the Pandemic and Beyond  

Featured speakers: Marcus Hughes, Associate General Counsel, UMass Memorial Health; Meg Cosgrove, Associate General Counsel, Beth Israel Lahey Health. And moderated by Jeremy Sherer, Healthcare Attorney, Hooper, Lundy, & Bookman. 

Hughes and Cosgrove discussed interstate telehealth compliance issues. They talked about the hard adjustments providers have to make as demand for telehealth surges and scrutiny of out-of-state practice increases. They shared ways they are preparing for the regulatory changes that will come with the end of the public health emergency.  

As waivers expire, Compliance officers have to increase their efforts at making sure providers understand licensing requirements and the risk of non-compliance. 

Hughes noted that there is a common belief that there is a national framework for remote care, but actually there isn’t. “Now that we’re in the late stage of the pandemic, we have to educate our staff to dispel some of the myths that are out there. And we have to make sure they know that the COIVD waivers are coming to an end.”  

Read More: Healthcare GCs look at telehealth compliance in the Pandemic and beyond

COVID-19 Hot Compliance Topics  

Featured speaker: Martie Ross, Office Managing Principal, PYA  

Ross covered federal vaccine mandates. unwinding regulatory flexibilities, and provider relief fund audits and enforcement. Her detailed slides are available from PYA here. They provide great insight for Compliance practitioners. 

Ross recommends that you review and track changes to internal policies and practices and establish a process to completely unwind. “As a compliance officer, it’s time to back through your compliance documentation over the past two years and think about how you’re going to unwind from these changes,” she said. 

Read More: Compliance expert Martie Ross explains critical regulatory change management issues facing healthcare in 2022

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.  

Subscribe to get the latest articles about healthcare regulatory changes.

Man typing on laptop
Request a demo of the YouCompli solution.

Five tips to help providers comply with Stark

The Stark Law creates a whole set of antikickback rules that providers must understand and actively work to comply with. And with all its good intentions, the Stark Law is incredibly restrictive. In fact, even the U.S. Court of Appeals for the 4th Circuit noted that “even for the well-intentioned healthcare provider, the Stark law has become a booby trap rigged with strict liability and potentially ruinous exposure.”

The Centers for Medicare and Medicaid (CMS) and Congress have taken steps to clear up confusion and loosen the rules in some cases (See our article on exceptions for value-based care). Still, your Compliance team has a tremendous responsibility to make sure that policies match the rules and that providers understand and follow the policies.

Policies match the Stark rules

Changes to the Stark Law have been coming out practically since the law was enacted. The law, which aims to protect against kickbacks and self-referrals, has gotten complicated in the details. Congress issues amendments to help  the law catch up to changing business practices. Healthcare organizations may have written policies that facilitated compliance originally. However, those may be completely out-of-date if they weren’t keeping up with the changes in the law.

For example, CMS has introduced modifications that addressed challenges with value-based care and resolve issues restricting coordinated care and health data exchange. Another modification to the law was allowing healthcare providers to accept cybersecurity tech donations from stakeholders.

While the compliance officer enforces the policies, he or she doesn’t have to live them the way those in operations do. Getting input from key stakeholders such as providers, Risk Management, and others in the C-suite can help ensure that final policies are clear. This early feedback and engagement can also help identify how the policy or regulatory changes will affect the individuals who must operate under them. Lastly, they can help identify potential operational conflicts with new policies or regulatory changes.

(See how YouCompli delivers model policies and procedures that help your organization comply.)

Providers following the Stark policies

With compliant policies in place, it’s time to help providers understand how to follow them. This is where communicating what certain key terms in a policy or regulation means in the context of the provider’s particular work becomes critically important.

Compliance officers know that “the road to success is going to run through quality of care,” says Harry Nelson, health care attorney at Nelson Hardiman. “Compliance isn’t the internal police that slows things down, but a strategic part of growth.” When it comes to making sure providers understand how to follow policies, the compliance officer has to look at the language of the policy from the providers’ perspective, not that of the compliance officer.

Here are five steps to help providers understand and follow Stark-compliant policies:

  1. Engage your operational leaders. Make sure the president and CEO understand the nature and intent behind Stark limitations so they can help explain and reinforce them. Give situational examples they can relate to so they understand what the key terminology means.
  2. Invest in training and communication. One email won’t do it with changes to Stark-related policies. Engage providers in small groups, in writing, and in person to explain nuances and answer questions about tricky scenarios. Whenever possible, use real-world scenarios to help illustrate how the regulations and policies impact them. Education and training should also be routine and ongoing with key stakeholders.
  3. Get feedback. Regularly check in to gather feedback from your leaders. Find out if the implemented tools and procedures are working for them, as well as to identify challenges they face. This step will help you see areas where the  words on paper mean something the compliance officer had not thought of. Adapt procedures and tools if necessary.
  4. Encourage people to ask questions. Make sure providers and your operational leaders alike know they can use you as a sounding board for grey areas or possible violations. It’s much better if they proactively ask if a proposed arrangement is compliant. Otherwise, they may have to unwind a relationship if they find out it is not compliant.
  5. Promote awareness to prevent future mistakes. Once an error is made, chances are it will reoccur and lead to additional violations. As you are addressing errors, promote awareness to prevent future mistakes. For example, when you are communicating the fact that a mistake was made, go the extra step to what caused it. This will be an opportunity to find out where their confusion was and use that insight to update policies or training.

Stark compliance starts with knowing about changes to the regulations and continues with crafting policies that providers can understand and follow. Involving stakeholders in policy creation and training, and engaging tech systems to reinforce the lessons will support the long-term success of Stark-compliant policies.

Do you have the tools you need to recognize and manage regulatory change across your organization? Find out how YouCompli can help you manage and coordinate your response to regulatory change or schedule a demo.

Subscribe for blog updates

Telehealth policies and programs center on patient care

Patients and providers alike flocked to telehealth in 2020. Before the COVID-19 pandemic began, fewer than one percent of Medicare primary care visits (PCV) were conducted via telehealth. By April 2020 that number had risen to 43 percent.  (See the data.)  

This spike was in response to fear of spreading the virus, of course. But it was only possible because healthcare organizations worked so hard to adjust to meet the ongoing patient needs. The federal government helped by announcing a public health emergency that eased key rules.  

Related: Differing state regulations make telehealth compliance more complex.  

Compliance professionals worked across their organizations to make sure that everyone understood and complied with documentation, coding and confidentiality requirements. For example, compliance professionals collaborated with clinical teams to ensure telehealth workflows were HIPAA compliant.  And, given the potential for abuse and scrutiny, providers who bill Medicare/CMS took extra care to document visits properly. 

Telehealth has been hugely popular with patients and has led to better visit compliance, particularly for uninsured and underinsured populations. Telehealth has improved patient care by allowing convenient appointments from the comfort of home via a smartphone, tablet, or computer. Another benefit is that telehealth has the potential to expand health care access to underserved populations by eliminating traditional barriers to care such as transportation needs, distance from specialty providers, and approved time off from work. These visits were essential for patients with limited mobility. And of course, there’s the most immediate and urgent benefit of telehealth:  reducing the spread of COVID-19 by limiting person-to person-contact.  

The work for the Compliance team and colleagues across the organization was significant. They had to determine how to maintain confidentiality, obtain consent, and determine proper billing codes. Despite the enormity of this task, the effort seems to be worth it. Patients are reporting that telehealth helps them take better care of themselves. According to Medical Economics:

  • 93% of patients would use telehealth to manage prescriptions, and  
  • 91% shared telehealth would help them stick to appointments, manage prescriptions and refills, and follow wellness recommendations. 

Providers seem to feel that they have worked through a lot of the challenges of telehealth compliance, especially when internet connections are stable. Nicole Craig is a Family Nurse Practitioner at Children’s Rehabilitative Services in Phoenix. She says compliance guidance helps providers “know what has to be documented in the chart to protect ourselves from things such as improper billing and coding.” And, “in 2021 the billing is now different. Getting help from Compliance allows providers to bill time-based care. We have to understand the billing rules and compliance factors in order to follow them, especially during telehealth visits.” 

For most PCVs, telehealth proved to be an efficient way to provide care. This method limited in-person visits to those instances where the patient needed a hands-on physical assessment or diagnostic testing.  

Isabella Porter, JD, director of Compliance at District Medical Group, Inc., is confident that 2020 created a rebirth of telehealth. She also sees a new appreciation of this method of care delivery which healthcare will not abandon once the pandemic is deemed “over.” And she knows that her team will be a big part of her organization’s success. “I do believe that in the context of telemedicine during COVID-19, our Compliance department’s assistance with telehealth workflows lead to overall better patient outcomes during the pandemic,” she said. 

It’s a good thing. While concern about the coronavirus will recede, providers and patients alike will want to continue some telehealth visits. Healthcare leaders will work collaboratively to ensure their organizations can continue to offer this important option.  

Keep on top of regulations affecting telehealth and make sure those regulations are translated into policies and procedures that affect patient care. YouCompli customers have access to notifications about changes to regulations, resources to inform policy and procedure updates, and tools to track compliance. Contact us today to learn more.  

Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.  

Subscribe to receive updates from YouCompli

Denise Atwood, RN, JD, CPHRM 
District Medical Group (DMG), Inc., Chief Risk Officer and Denise Atwood, PLLC 
Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.