Significant updates to the Safe Harbors and Civil Monetary Penalties under the Anti-Kickback Statute related to beneficiary inducements went into effect in January 2021. The Office of Inspector General’s final rule aims to improve patient care overall. It will accelerate the transformation of the healthcare system into one that pays for better value and promotes coordinated care.
The regulatory changes are notable partly due to the number of patients affected. In 2020, 62.6 million people were enrolled in the Medicare program – almost 20 percent of the U.S. population. Under the revised rule, the goal is for value-based arrangements to shift financial risks from Medicare to the healthcare provider or organization.
The benefits of better coordinated care
With reduced regulatory barriers to care coordination, patients should receive value-based care provided at a reasonable cost. Payers can set expected outcomes for care and by not reimbursing for substandard care or overutilization of unnecessary care.
This means patients will receive and utilize services, such as advanced medical imaging including MRIs and CTs, only when they genuinely need them. Also, a new safe harbor supports increased care coordination by allowing tools and supports to be furnished directly to patients.
Again, the intent is to improve the quality of patient care and health outcomes. For instance, a provider could give a blood pressure cuff to patients managing hypertension. Or an organization could create a phone app to record food intake and blood glucose levels for those with diabetes.
Another positive: pharmacies are now allowed to offer certain vaccines at a reduced price or for free. Removing financial barriers should increase vaccination rates, which is beneficial from a public health perspective as well as a risk and compliance perspective. Ideally, it will encourage healthcare staff to receive COVID, flu, and pneumonia vaccines, thus decreasing patient exposure to these illnesses.
In addition, the final rule broadens the safe harbor for cybersecurity technology and services and may permit remuneration of cybersecurity-related hardware. This could reduce financial barriers for healthcare organizations looking to upgrade their technology to decrease breach risks. In turn, it would improve patient care by decreasing the risk of protected health information getting into the wrong hands.
Compliance learning curve
From a compliance perspective, the early days of implementation – as with any regulatory change – may be frustrating. Before, compliance officers were familiar with the clear exclusions under the Anti-Kickback Statute and its very few safe harbors. Complying was straight-forward: inducements to remuneration to patients were generally prohibited.
Now, compliance officers must get up to speed on when organizations and patients are allowed to receive some remuneration under value-based arrangements or cyber-security safeguards. With the new safe harbors, healthcare organizations might offer free transportation or expanded telehealth services – without fear of civil money penalties and fines.
As a strategic business partner, compliance officers can support their organizations in implementing the rule changes and mitigating risks. Compliance officers can
- Conduct walking rounds or hold virtual town hall meetings to discuss the changes with staff.
- Meet with operations leaders to highlight internal tools and resources available for improving patient care while complying with new safe harbors.
- Partner with IT leaders to see which cybersecurity hardware is needed and permissible under the new rule.
Compliance officers may initially scramble to keep up as healthcare organization leaders think of innovative ideas to improve patient care. Yet the end goal – providing better value and coordinated care for patients – is worth it. Long term, both patients and healthcare organizations will benefit from a system that provides value-based care at a reasonable cost.
How is your healthcare organization keeping up with changes in regulations? Read more about our regulatory monitoring process.
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.
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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