In order to operate, non-profit organizations rely heavily on the ability to fundraise. The government leaves the regulation of that “charitable solicitation” to individual states, with most requiring formal registration to engage in such activities. With firms vying for organizations’ business to hire consultants to obtain funds, and ethics and oversight firms highlighting the careful approaches that must be utilized to appropriately raise funds for non-profit operations, charitable organizations may find themselves confused and threatened in the space between needing charitable solicitation to survive and maintaining regulatory compliance to engage in the activity itself. While the threats of penalties and sanctions are large and imposing, it appears that few organizations ever face their true weight. Charitable organizations must, of course, comply with each state of registration, but is the fear instilled equal to the reality of the consequences of non-compliance?
Cheryl Miller is the Director of Risk, Compliance and Legal – and Chief Compliance Officer for Presbyterian Homes, a Life Plan Community (formerly branded as a Continuing Care Retirement Community (CCRC)) in Skokie, Illinois. Ms. Miller worked as a corporate paralegal for several years before and during law school, first at a large law firm and then at Brookdale Senior Living. She moved into healthcare regulatory work, and from there learned about the Health Care Compliance Institute and went to the annual meeting. “The preciseness of Stark and Anti-Kickback and the other multitude of regulations enthralled me. I was on-site at a client (Presbyterian Homes) two days per week providing risk management services. I asked about their compliance program and gave (what I thought was) constructive criticism. A year or so later, Presbyterian Homes hired me away from the firm.” Ms. Miller was recently invited by Professor Larry Singer to speak to his Health Care Business and Finance class about the Long-Term Care industry. Her discussion enlightened many of the students and inspired enrollment in Loyola’s Long-Term Care course. The following is an interview that highlights her insight and experiences about her work in an often-overlooked area of healthcare.
Since the enactment of the Affordable Care Act, hospitals have faced strict and substantial regulations regarding the provision of financial assistance to patients in the form of “charity care.” An essential element in a hospital’s ability to maintain tax-exempt status and financial solvency, charity care has worked to serve uninsured and indigent patients while helping charitable hospitals serve their mission and retain the benefits that come with it. The state of Pennsylvania recently passed legislation requiring more explicit and affirmative acts to provide charity care to more eligible patients. The change is unprecedented, and other states look to be slowly responding in their own ways. Compliance with these changes is most beneficial with proactive measures and risk assessments even before change comes through the doors.
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.
In October 2015, the tenth revision of the International Classification of Diseases (ICD-10) was implemented in the United States. Three years earlier, however, ICD had already begun beta testing for its eleventh revision (ICD-11). The ICD-10 implementation came after repeated delays and substantial requirements for healthcare organizations to reach compliance with the new codes. The United States trudged through training and compliance struggles as it transitioned to ICD-10. The threat of ICD-11’s release in 2018 promises to have drastic and far-reaching effects on the compliance actions of healthcare organizations.
Physician Assistants (PAs) have long been recognized as clinicians working under the supervision and guidance of physicians. In recent years, advocacy efforts have shifted to encourage the recognition of PAs as team-based practice clinicians working in collaboration with physicians. State legislation is beginning to reflect those efforts, as one by one, states begin to update the governing rules and regulations. As that future nears, compliance efforts must be able to effectively respond and adjust to these changes in a timely manner.
States looking for flexibility or creativity in implementing Medicaid programs can apply for waivers from the Secretary of Health and Human Services (HHS). According to the Medicaid and CHIP Payment Access Commission (MACPAC), waiver use is quite extensive—resulting in “wide variations in program design, covered services, and eligible populations among states and even within states.” As of September 2017, 33 states account for 41 approved waivers, and 18 states have 21 total pending waivers. The scope of these waivers traditionally broadens eligibility and creates new programs in states where Medicaid needs are not expressly recognized by federal law. Current pending applications suggest, however, that states seeking waivers now do so as a means to circumvent Medicaid program requirements they disagree with.
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.