Stark Law: Flexibility for value-based care

The well-intentioned but complex Stark Law has gotten some updates recently. The changes give healthcare providers greater flexibility, especially with value-based care. 

The Stark Law was introduced in 1989 by United States Congressman Pete Stark (D-CA). It aims to protect Medicare and Medicaid from paying for services that may trigger conflict-of-interest concerns. This includes certain healthcare services for which physicians referred their Medicare/Medicaid patients to an organization with which they have a financial relationship. Referrals like this trigger questions about whether the patient really needed the service and raises concerns of physicians referring for their own financial benefit.  

Take, for example, a physician who refers a Medicare/Medicaid patient for an x-ray to a medical imaging facility. The facility then bills Medicare for that service. This may seem appropriate unless the physician has a financial interest in the medical imaging facility.  

The law faced criticism, however, for being too rigid. According to Henry Casale, partner at Horty Springer, “providers have found that the Stark Law is deceptively simple to summarize, but compliance has proven to be difficult and complex.” 

Casale went on to say that “Stark said that ‘the only way to protect healthcare consumers from unnecessary referrals is to impose a bright line rule.’ The Stark Law prohibits a physician from making referrals for certain Designated Health Services (DHS) payable by Medicare or Medicaid to an entity with which the physician (or an immediate family member) has a direct or indirect financial relationship (ownership or compensation). It also prohibits the entity from filing claims with Medicare or Medicaid for those referred DHS, unless the financial relationship complies with an exception to the Stark Law.”  

New value-based exceptions 

New exceptions under Stark allow for physicians to refer Medicare/Medicaid patients to entities they have a financial relationship with and that are part of a value-based program, in some cases. Additionally, the physician may receive remuneration, such as cost savings payments, so long as the requirements of the new exception are met.  

According to Casale, “The Stark value-based rules cover both cash and in-kind remuneration and do not include the term ‘Fair Market Value’.”  These rules have a number of requirements, but those requirements decrease as the value-based physician participants assume more financial risk.  The greatest flexibility is when the physician participants agree to assume full financial risk. (This includes capitation and global budget payment arrangements.) The requirements increase if the physician participants assume only “meaningful” financial risk. (The physician is responsible to repay or forego no less than 10 percent of the total value of the remuneration the physician receives under the value-based arrangement.) The requirements are greatest where the physicians are not at financial risk. 

“The Stark value-based rules are a significant improvement,” Casale said. “But they do leave a number of questions unanswered.” They also differ markedly from the OIG’s value-based safe harbor regulations that were published the same day, especially where the physicians are not at financial risk.  Here the OIG only provides safe harbor protection for in-kind remuneration while the Stark rules permit both cash and in-kind remuneration.  

“So while the Stark rules provide guidance and significant flexibility,” Casale said, “providers need to also consider the OIG’s much more narrow view of value-based arrangements.”   

RelatedDiscover how CMS is improving patient care while reducing administrative burden for providers. 

Rules related to Stark and anti-kickback legislation have been evolving for decades. These recent changes reflect an effort to add greater flexibility with value-based care and help keep the law responsive to current business practices in healthcare.  

How is your healthcare system adapting to keep up with changes to rules from the Stark Law and other fluid regulations?  Read more about how YouCompli can help you stay on top of regulatory changes or schedule a demo. 

Jerry Shafran

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 has founded, managed, and sold software and content solutions that simplify complex work. His innovations enable professionals to focus on their core business priorities.

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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.  

RelatedDiffering 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.