On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989. As CMS tries to reconstruct the healthcare field, it is imperative for compliance programs to prepare for the changes in regulations to come. The following discussion provides a brief overview of the proposed changes but is not an exhaustive list of all rulemakings related to the physician self-referral law.
In August, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) made an additional focus in its Work Plan for the oversight of nursing facility staffing levels. These changes were made in the light of backlash from a July 2018 news article which reported that nearly 1,400 nursing homes had fewer qualified staff on duty than they were required or failed altogether to provide reliable staffing information to the Centers for Medicare and Medicaid Services (“CMS”).
In the graphic novel and film “The Watchmen,” there is a reoccurring phrase: “Who watches the watchmen?” In context, it’s an indictment of the comic book world’s broken justice system. However, in a compliance context, the concept can be just as important. In a recent discussion with a hospital system’s compliance officer, he raised the point that a company’s compliance department is seen as the ultimate authority and expertise in laws and regulations, monitoring compliance and noncompliance, and implementing corrective and disciplinary actions. Yet while many compliance professionals may assume that their actions are always compliant, who oversees those who are overseeing systems and organizations? Who ensures that compliance is compliant?
After years in an opioid crisis, the United States now faces an opioid epidemic that has left the government and public desperate for relief and a workable solution. A group of senators hopes to be part of the solution with the introduction of a bipartisan bill that aims to better enable the DEA to establish opioid quotas. Despite already-present struggles to effectively manage its quota system and policies, the DEA would be given significantly more responsibility under this bill. Drug manufacturers, directly responsible for following DEA, FDA, and OIG regulations to hopefully resolve the epidemic, will need to grow their compliance efforts and create responsive solutions to remain both profitable and compliant.
Landlords have a duty to know the laws applicable to their properties, in all matters great and small. While security deposits may seem on the “smaller” end of a landlord’s duties, he or she must remain compliant with all state and local municipal laws—even when handling security deposits. Whether a large or small residential unit landlord in the City of Chicago, a violation of the state and municipal security deposit laws can have a catastrophic domino effect, resulting in lost revenue, penalties, and lawsuits. In fact, some landlords have had to shell out six-figure settlements and file for bankruptcy as a result of violating the laws surrounding security deposits.
In the eyes of underinsured or uninsured patients, Patient Assistance Programs (PAPs) offer access to otherwise unaffordable medications. However, there are questions being raised whether PAPs are being abused by manufacturers as an inappropriate inducement. The government is increasing its inquiries into PAPs and is beginning to take more investigative action. PAPs are often funded by charitable donations from companies who benefit from the PAP paying for co-insurance for the very drugs the company manufactures. It is essential for companies seeking to develop or maintain charitable donations to remain compliant with existing regulations, but also be aware of forthcoming regulations as a result of present actions.
This summer I had the opportunity to intern with the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) in Washington, DC. I thoroughly enjoyed my time with OIG, and I learned a great deal about health care fraud, waste, and abuse. In spending my summer with OIG, I had a glimpse into the powerful regulatory bodies that protect the health care market from abuse. As I move forward with my career in regulatory work, I will take with me the invaluable experiences and skills from my internship.
Ryan Meade Editor-in-Chief Director of Regulatory Compliance Studies at Loyola University Chicago School of Law A recent commentary from the U.S. Department of Health & Human Services’ Office of Inspector General (HHS-OIG) indicates it will not consider the existence of an effective compliance program as a positive factor in resolving civil non-compliance but it …