Legal Matters

Avoiding Beneficiary Inducement Trouble When Providing Self-Monitoring Technology to Patients

By Stephen M. Angelette, J.D. Shelby D. Zumwalt, J.D. Polsinelli, PC

More and more patients are taking advantage of wearable devices to allow their healthcare providers in gaining insight on their care, whether monitoring heart rate, glucose, stress, or weight. Some providers would like to provide patients with this wearable technology for no charge to assist in their care. But this approach has historically been limited by federal regulations related to beneficiary inducement.

Under the beneficiary inducement prohibition (“BIP”), the OIG may impose civil monetary penalties against any person who offers or transfers any remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a provider, or supplier of any item or service reimbursed by Medicare or Medicaid. The BIP defines “remuneration” to include any transfer of value, including items or services for free or less than fair market value. In the Affordable Care Act (“ACA”), Congress created several exceptions to the BIP. Relevant here, the ACA created an exception that permits remuneration to a beneficiary if the remuneration meets two elements: the remuneration (1) promotes access to care and (2) poses low risk of harm to patients or to Federal health care programs. This exception is commonly referred to as the “Access to Care Exception.”

In 2016, the OIG issued a regulation interpreting the Access to Care Exception and its elements. In the regulation, the OIG interpreted the “promotes access to care” element to require that the remuneration “promotes” access to care by “improving a particular beneficiary’s… ability to obtain items and services payable by Medicare or a State health care program.” This includes providing patients with tools to remove socioeconomic, educational, geographic, mobility, or other barriers to accessing care. The OIG specifically noted that “[S]martphone apps or low-cost fitness trackers could, depending on the circumstances, promote access to care.” The OIG also explained that permissible remuneration “removes an impediment or otherwise facilitates compliance with a treatment plan.”

In the 2016 regulation, the OIG interpreted the “poses low risk of harm” element to require that the remuneration (1) be unlikely interfere with, or skew, clinical decision making; (2) be unlikely to increase costs to Federal health care programs or beneficiaries through overutilization or inappropriate utilization; and (3) not raise patient-safety or quality-of-care concerns. Regarding overutilization and increased costs, the OIG explained there may be an increase in costs due to an increased access to care, but the concern is where remuneration would increase cost through overutilization or inappropriate utilization such as access to a higher level of care than necessary.

see Legal Matters...page 14

Early Detection of Alzheimer’s Disease Goal of New Research Project from Rice Neuroscientist

Leal Hopes to Discover Interventions That Prevent Or Slow Progression

By Amy McCraig

More than 6 million Americans are living with Alzheimer’s disease, for which there is no cure. Early detection is critical to managing symptoms. A new research project led by Rice University cognitive neuroscientist Stephanie Leal will focus on improving early detection methods through the use of highly sensitive memory tasks and brain imaging — which someday may even lead to a cure. “Rather than treating the symptoms of Alzheimer’s disease, at which point the damage done to the brain may be irreversible, we are hoping to understand the earliest cognitive and brain changes, which should get us closer to determining the cause of the disease,” Leal said. Researchers have begun to zero in on which regions of the brain should be examined for possible signs of Alzheimer’s decades before symptom onset. However, Leal said research has not previously used memory tasks sensitive enough to detect the earliest changes in memory that could be a symptom. “Even in cognitively normal older adults that don’t have clinical symptoms of Alzheimer’s disease, we can still pick up on these memory deficits that are happening and may just seem like normal aging to the individual or their family and friends,” Leal said. Highly sensitive neuroimaging ( MRI and PET scans) is used to examine extremely small regions of the brain that are critical to memory and are impacted before symptoms develop. The technology has only recently evolved to the point that viewing these regions is possible, Leal said, and pairing it with the sensitive memory tasks could provide warning of future onset of Alzheimer’s early enough to improve long-term outcomes. The research is funded by a grant from the BrightFocus Foundation. More information is available online at https://science.brightfocus.org/ alzheimers-disease-research/grant/ more-sensitive-measures-towards-earlydetection-alzheimers.

LIVE. WALK. SHOP. DINE.

HANOVER RICE VILLAGE HANOVER SOUTHAMPTON