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 However, those may be completely out-of-date if they weren’t keeping up with the changes in the law.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.

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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.  

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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.  

Take as directed: Medication compliance and the Compliance office

Working toward higher rates of patient medication compliance is a critical component of patient care. That includes communicating what the medications are, what they do, and how to take them. Providers are keen to ensure they provide clear directions and to be sure patients can pay.  

It’s no wonder they take such care: Each year, about 125,000 Americans die due to poor medication adherence, according to the American Heart Associationi. Improper compliance practices come with a hefty price tag of $528 billion in annual expenses, according to a 2019 OptimizeRx surveyii.  

What’s more, medication mismanagement is a strong predictor of hospital readmission rates. Individuals who failed to take prescribed medication as directed had a 20 percentiii chance of hospital readmission within 30 days, compared to 9 percentiv for patients who take meds as directed.  For the compliance officer, keeping hospital readmission rates low is crucial to avoid wasteful spending, per the Centers for Medicare and Medicaid guidelines.    

So many factors contribute to whether a patient properly follows through with medication instructions. Providers and administrators alike do their best to put systems and communications in place that make compliance easier. While not within a compliance officer’s direct control, there are policies and procedures that can help hospitals comply with CMS requirements to lower readmission rates. This helps facilitate better health outcomes and increased quality of life for patients.    

So how can you ultimately help patients improve medication management skills? Here are a few tips you can include in your medication compliance plan to help reduce readmission rates. 

Discuss side effects 

Patients who experience side effects may stop taking their medication altogether; without discussing this decision with their healthcare provider.   

That’s why it’s so important for doctors to discuss common and possible side effects with patients.  

Work with healthcare providers at your facility about how they can discuss any treatment plan changes to lessen the chances of side effects. Make it known that the treatment plan may include adjusting the dosage or changing the medication altogether.  Cut Out Distractions 

According to BMC Health Services Researchv, three out of five patients often forget to take their medication.   

Are distractions the main culprit? Encourage providers to discuss the importance of taking meds at the same time each day.  

Maybe patients can use a cell phone alarm to set up reminders. Taking multiple medications at different times? The workaround may be to set other alarm times for numerous times during the day.  

To make things even easier on patients, providers may consider prescribing once-daily medications.  

Providers may consider collaborating with the patient on the best time to take the medications when distractions are at their lowest.  

Money worries 

Sometimes the issue of medication compliance comes down to cost. About 70 percentvi of physicians link high prescription costs to a lack of medication adherence.  

To save money, they may ration meds or not take them at all.  

In a study published in Circulation, viione in eight patients with heart disease didn’t take prescribed medication because of the expense.  

Luckily, there are resources such as GoodRx, an app that allows anyone to shop at local pharmacies for the lowest prescription medication prices.   

Doctors can also prescribe generic versions of meds whenever possible to cut back on costs.   

Communicate more 

Poor communication is a deterrent to medication compliance, which is in turn linked to poor health outcomes.  

Fortunately, Motivational Interviewing can help. With Motivational Interviewing, health care providers are encouraged to ask open-ended questions beginning with What, Why, How, and When during discussions about medication usage. This technique is shown to improve behavioral change and adherence, as reported in Perspect Public Healthviii.   

This PDF by The Motivational Interviewing Network of Trainers provides more information on motivational interviewing.  

Medication compliance helps patients experience better health outcomes, reducing readmission rates and helping the hospital avoid tripping CMS’s indicators for fraud, waste and abuse. While much of the responsibility lies with the patient, hospital policies and procedures can help ensure the patient has the best possible chance to understand and comply with medical guidance.  

YouCompli helps healthcare facilities know about regulations, decide if they apply to them, manage policy and procedure rollout, and verify compliance efforts. Learn more 

i American Heart Association 
ii OptimzieRX survey 
iii 20 percent 
iv 9 percent 
v BMC Health Services Research 
vi 70 percent 
vii Circulation 
viii study 

Weaknesses in Internal Controls: How to Manage and Mitigate Vulnerabilities

weaknesses internal controls

Revised September 2022

Risk in US Healthcare

It is incredibly difficult to turn off “work brain” after the day is done.  Thoughts and questions keep creeping in during off work time, personal time.   

For example, did I send the new state law privacy requirements to our IT security team to review? Are the staff following and appropriately documenting for telehealth reimbursement?  Or what should be my priorities on Monday morning? These questions all represent potential weaknesses in internal controls.  Let’s explore what can be done to mitigate or decrease any vulnerabilities. 

It is important to have appropriate internal controls supported by open communication between colleagues, and forthright reporting to both compliance and risk departments in an organization. 

Since organizations are still run by humans, there remains the potential that one human sets up a call to discuss a topic (like a regulatory change), and inadvertently forgets to invite all the other humans affected by the change. Having a process in place where an employee discusses a need to meet with his or her supervisor can help ensure you’ve got the right humans at the table.  

Internal controls must also be communicated to the staff so they can adhere to the organization’s expectations and policies. This is where education, early and often, that includes the why behind the internal control, can provide the best results to reducing any vulnerabilities. 

Top Areas of Risk

Top areas of risk to a healthcare organization include weaknesses or vulnerabilities in security, documentation, operations, and staff performance.  Let’s consider the following: 

  • The risk focus for organizational security typically includes areas like information technology (IT) and physical buildings. Cybersecurity data leaks or active shooters are examples of each.  
  • Incomplete, non-existent, or fraudulent medical record documentation is another large risk for health care organizations. 
  • Lack of clear policies, procedures, or protocols (PPPs) present huge risks to the organization as employees may act in a way which is not in compliance with PPPs. 
  • And finally, human error, even if unintentional, can present costly risks to the organization, such as a Stark law violation. Both the strongest and the weakest internal control for health care organizations involves the staff.  Take cybersecurity: many data leaks come from staff clicking on the wrong link or attachment and letting the “bad guys in” to the network. The same is true when an employee lets someone in the building on their badge scan rather than making them badge in themselves.  

Mitigate Risks

Risk mitigation is an organizational strategy to prevent or decrease the impact of mistakes or unanticipated outcomes when they occur.  One strategy is to implement organizational controls, such as PPPs along with checklists and tools, to either prevent or decrease organizational risks. 

  • A primary and effective way to mitigate risks to the organization is to empower the employees with knowledge. Don’t just have employees complete compliance and risk education online.  Go out and meet the staff and answer their questions in real time!  Or encourage them to call or email their questions and provide timely follow up. 
  • Risk and compliance departments should foster a culture of early reporting by staff when there is a mistake or unanticipated outcome or a deviation from the PPPs. When a staff member makes a report, it is important to document the facts while remaining objective and non-judgmental. (Related: Read Brian Kozik’s story of changing the consequence structure to support a safe to speak up culture) 
  • Ensure you have a usable system to track internal control weaknesses to manage and mitigate vulnerabilities. Whether this is a manual process or is done through an IT application, make sure you consistently use the internal controls to evaluate and mitigate risks because they change – frequently. 
  • Review, or if you don’t have them, develop cybersecurity and business continuity plans. These plans should be living documents that are used regularly and revised at least every two years, to ensure compliance and risk topics are current and mitigated.  These plans should not just be a book on the shelf or a file on a computer. The risk focus for these plans should include tools to monitor both IT and the physical building risks. 
  • Commit to being a leader when it comes to promoting an open culture for reporting weaknesses, or breaks, in internal controls so early mitigation strategies can be implemented. 

Proactively setting internal controls helps you and your colleagues address mistakes and errors when they inevitably do happen.  While there is no failsafe way to ensure 100% compliance with internal controls, or that all employees will do the right thing every time, you’ll be better positioned when staff are educated and equipped to comply with regulations and do the right thing.  And in organizations that have an open culture of reporting, both the risk and compliance teams will be aware of the internal control weaknesses so they can implement mitigation strategies early on. 

 Strong internal controls are critical to effective regulatory change management. YouCompli can enable your collaboration with compliance champions and free your time to focus on relationships and communications. Take a look at our regulatory change management solution today.  

Jerry Shafran is the founder and CEO of YouCompli. He is a serial entrepreneur who builds on a solid foundation of information technology and network solutions. Jerry launches, manages, and sells software and content solutions that simplify complex work. His innovations enable professionals to focus on their core business priorities.

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Improving Your Reputation: How to Help Your Healthcare Organization See the Compliance Department in a Positive Light

When the compliance team visits another department, staff responses are usually the same: we must have done something wrong.

This isn’t the response that you want. The compliance department and staff should be seen as approachable, working in a collaborative fashion to make the organization more successful. If the compliance department only comes in to run audits and give “constructive” feedback, then compliance will quickly become known for negativity and criticism.

Collaboration

It is important to collaborate with other departments and incorporate a holistic organizational approach. This means valuing what other team members have to offer with regards to compliance in the organization. It can be easy for compliance professionals to make black or white statements regarding compliance with a specific regulation or policy. After all, it’s there in writing — in black and white.

But, other teams can sometimes bring to light another perspective. There may be gray areas in the written requirements or overall process and addressing these could benefit the organization without compromising compliance.

Or, compliance professionals could demonstrate openness to evaluating how requirements and regulations are impacting specific operational workflows. For example, when evaluating a compliance process for telehealth visits related to obtaining consent, the operations leader should be given an opportunity to work with compliance in developing the process.

In-Person Education

One approach to improving collaboration with other departments is to conduct in-person education and question and answer (Q&A) sessions. Ask all department leaders if you can have ten (but no more than fifteen) minutes at their next staff meeting to introduce the compliance team and to solicit compliance-related topics and questions. Before the meeting, make sure to get the department leader to provide two to three compliance-related topics that would be of interest to their team. Prepare a short slide presentation to use in the meeting — typically, one slide per topic and one Q&A slide at the end.

During the meeting, make sure to leave at least five minutes for compliance Q&A. Listen to the staff questions and solicit information on challenges or knowledge gaps related to compliance, so follow up can be done with the that department or team.

Follow-Up Education

Follow up should be timely (within three to four weeks) and can be done a few different ways: short videos, posts on the internal intranet or website, email education, or additional in-person follow up education. There are several excellent (and free) applications available online where you can create short, two- to three-minute compliance videos that can then be distributed to staff.

Follow-up education could also be done by email if the topic and question and answer lends itself to an email response. For example, if staff ask a question about HIPAA’s application to texts or emails, it would be fairly easy to find a one-page summary on the application of HIPAA to texts and emails and attach that to an email.

Volunteers

Another way to improve collaboration would be to have compliance staff volunteer to participate in organization committees not directly related to compliance. For example, compliance professionals could join the policy committee or the activities committee. In this way, the compliance team can develop positive relationships with others in the organization, in an open and approachable way.

Practice Tip:

  1. Reach out to at least 3-4 departments before the end of the year to schedule and conduct in-person meet and greets with a focus on compliance education.
  2. Utilize services such as youCompli to stay current on compliance topics and regulations to present during your meet and greet meetings.

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

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.  

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