In this new age of patient centricity, the focus of the pharmaceutical industry is starting to shift from developing relationships with healthcare providers to establishing services and solutions around the patient. This shift arises from the complexities of disease states and the associated disease management options, as well as increased complications in the approval of treatments by insurers. Companies are beginning to create patient services programs to aid patients in the use of their products by providing educational support and reimbursement services. These services can include the provision of free drug, co-payment cards, or other financial assistance to help with the cost of the prescription drug for individuals, conducting benefits investigations with patients’ insurance companies, or providing educational support in disease management. Additionally, patients are increasingly becoming a valuable source of insight and knowledge as opinion leaders, especially in specialty or rare diseases where there may be limited treatments and options for the affected patient population.
In recent years, pharmaceutical and biopharmaceutical manufacturers have begun receiving more attention and scrutiny from government and public entities regarding various offerings of their patient support services programs. One reason behind the attention to these programs has been the country’s focus on prescription drug pricing. Even Congress is beginning to include components of patient services programs in examining drug pricing and in many of its recent investigations of specific companies. Additional attention to co-payment programs and drug costs have stemmed from the August 2016 Government Accountability Office Report on co-payment coupons, which concluded that coupon programs provided to privately insured patients could impact Medicare Part B Drug spending.
Media articles have also started calling attention to the relationships companies are building with patients. The Washington Post recently investigated the practices of companies that sometimes go beyond providing financial assistance for drugs by offering grants and gifts to patients and that “may mask an effort to create customer loyalty or sell pricier drugs for a rare disease.”  Furthermore, Bloomberg Businessweek featured an investigation of one company’s aggressive practices in finding rare patients and directing physicians to prescribe its drug. 
Due to the changing landscape of healthcare reform, as well as the increased number of specialty pharmaceutical products, this new attention on patient services compliance is becoming a growing risk that companies must address in order to continue to successfully help patients through their patient services programs.
The patient journey
While there are many business and process considerations related to patient services programs, if not managed or executed correctly, these programs can increase companies’ risk for litigation and investigation (Fig. 1). When looking at their programs, companies must consider the overall patient journey. What activities along the path are subject to risk? Who are the key players that partake in such activities? Who should be performing these activities? Is there a legitimate need to provide these activities to the patient? Can these services be provided to the patient by a pharmaceutical company or its agent?
Companies offer different patient support services based on their specific products and disease state. Support activities can be managed internally or be outsourced to “Hubs” or specialty pharmacies. Hub vendors can provide a centralized approach to ensure manufacturers are connected to patients, healthcare providers and insurance providers, throughout the patient journey from prescription to delivery. Specialty pharmacies are often utilized by manufacturers for the distribution of high cost, high touch and/or high complexity treatments and therapies for complex disease states. Manufacturers often outsource all or portions of their patient services programs to these Hub vendors, as well as specific patient support services to specialty pharmacies.
Without established controls and processes and appropriate training within these patient services activities, companies put themselves at risk for potential violations of various laws and regulations.
Recent enforcement activity has focused on alleged violations of the Anti-Kickback Statute through the usage of Hubs and specialty pharmacies to increase product utilization. In a survey focused on patient services conducted earlier this year by Helio Health Group across pharmaceutical companies of various sizes, 65% of companies surveyed use Hubs to outsource patient services activities that they may not have the resources to manage internally, such as conducting benefits investigations. Companies are also increasingly using specialty pharmacies for the distribution of high-cost drugs for complex and rare diseases. However, companies providing performance incentives (e.g., patient referrals or higher rebates) to specialty pharmacies based upon refill rates are at risk of violating the Anti-Kickback Statute.
Under the Anti-Kickback Statute, it is a criminal offense for manufacturers to “knowingly and willingly” provide any patient who is fully or partially insured by a Federal healthcare program (i.e., Medicare, Medicaid, Veterans Affairs, Indian Health Services, etc.) with any form of a co-payment assistance. In 2014, the Office of the Inspector General (OIG) issued specific guidance on the topic. 
Similarly, specialty pharmacies will also be held responsible for patient programs that are at risk of violating these government statutes. Recently, Walgreens settled for $50 million with the Manhattan US Attorney’s office for marketing its Prescription Savings Club program with “discounts and other monetary incentives” to government beneficiaries and providing its employees bonuses “for each customer they enrolled in the program,” violating the Anti-Kickback Statute. 
Furthermore, regulatory authorities have been investigating the relationship between companies and charitable institutions who provide patient assistance programs (PAP). Many manufacturers provide financial donations to charitable institutions who provide financial assistance to patients with specific disease states. These charitable institutions may provide patients insured by Federal healthcare programs with financial assistance, including co-payment assistance, as long as the charitable institution remains independent from the manufacturer in all of its decisions and activities. The OIG has issued guidance on Independent Charity Patient Assistance Programs, including a Specialty Advisory Bulletin, a Supplemental Special Advisory Bulletin, Advisory Opinions and Modified Advisory Opinions, which outline specific requirements of independence for these programs. Companies who provide grants to these charities and then influence the provision of financial support for their products or guide the direction of the charities’ financial provisions may be at risk of violating the Anti-Kickback Statute. Over the past two years, the US Department of Justice (DOJ), led by the US Attorney’s Office of Massachusetts, has issued more than a dozen subpoenas to manufacturers related to their donations to charitable patient assistance programs and this topic has received additional media attention.
False Claims Act
Many patient support services include patient educators whose role is to provide the patient with information on the approved use of a company’s product and to educate the patient about the disease state for which the product is approved. In many cases, patient educators are trained nurses or other healthcare providers. However, when acting as an employee or agent of a pharmaceutical company, they are not allowed to provide medical advice to patients under the False Claims Act. Companies who hire patients to function as patient ambassadors or advocates to speak on their behalf are also required to abide by the same requirements. Companies should be diligent to train their patient educators, patient ambassadors, patient advocates, and all other patient services team members on responding to medical questions and inquiries from patients to avoid these potential issues and to understand that their role is not to provide medical advice to the patient.
Companies that provide patient services support to coordinate and assist with patient enrollment tasks must ensure the services provided are not influencing medical decisions or working towards favorable coverage determinations to avoid violating the False Claims Act. The Warner Chilcott 2015 guilty plea to the District of Massachusetts included a $125 million payment to resolve criminal liability and False Claims Act allegations for “manipulating prior authorizations to induce insurance companies to pay for prescriptions of Atelvia® that the insurers may not have otherwise paid for and making unsubstantiated marketing claims for the drug Actonel®.” 
In the most recent opioid investigation conducted by Sen. Claire McCaskill’s office, the report focused on patient services reimbursement and prior authorizations support from Insys Therapeutics. The report “describes the emphasis Insys Therapeutics put on boosting approvals for its highly addictive fentanyl drug Subsys, even for inappropriate, off-label uses, and details an audio recording in which an Insys sales representative misidentifies herself and uses language designed to circumvent the prior authorization process.” 
Health Insurance Portability and Accountability Act (HIPAA) and data privacy
While patient centricity emphasizes the importance of patient information, the lack of firewalls and policies may create risk in patient consent and information sharing. In the same survey, 19% of companies stated that sales representatives have access to patient data or information, and 15% of companies share both patient name and medical history between functional areas within the company. Inappropriate access to protected health information (PHI) may create the risk of violating HIPAA regulations, especially if patient consents do not include the ability to share this data.
Federal Food, Drug, and Cosmetics Act/off-label
Patient educators are often utilized in a patient services program to inform the patient of the on-label or US Food and Drug Administration (FDA) approved use of a company’s product. Companies are at risk of potentially violating the Food, Drug, and Cosmetics Act if the information shared with patients does not adequately cover the safety and efficacy details, and thus does not represent a fair balance of product information. Providing information to patients about usage of a product for an off-label indication, an indication that is not in FDA-required labeling of the product, may also put a company at risk. Interestingly, 20% of the companies surveyed indicated that they do provide patient support services in the form of free drug, reimbursement or co-payment support, and education to patients who are using their products for an unapproved indication. Companies must consider how to balance the risk of providing certain services to patients who are using their drug off-label, and which patient services are appropriate to provide or may cause potential liability for the company. Considerations and risks for off-label patient support services are complex, especially with the new debates around first amendment rights as well as FDA’s recent guidance on the issue. [7,8].
Adverse events identification and reporting
Patient support services also pose additional risks to pharmacovigilance, and the accurate and appropriate capture and reporting of adverse events. Ensuring adverse events and product quality complaints are accurately captured and reported becomes increasingly difficult as more information is shared amongst the patient, caretaker, physician, Hub, specialty pharmacy, or internal patient services team members given the direct relationships and activities with patients. As the number of individuals interacting with patients is increasing with these programs, it is important for companies to remember that the potential number of adverse events and product quality complaints may increase. Proper training on identifying and reporting of adverse events to all employees and vendors who interact with patients may be a key factor in remaining in compliance and reducing risk in this area.
How do companies ensure that their patient services programs provide the optimal value to patients while remaining compliant?
One consideration is to evaluate where the patient services group sits within the organization and the reporting structure. Although 33% of companies surveyed stated that the patient services team has its own dedicated group, 41% stated that the patient services team is located within the Brand/Commercial group. For patient services teams that include patient educators, it may be a potential risk for the patient educators to report into sales without establishing strong controls to ensure nurses are not speaking to patients in a promotional nature.
Another consideration is to examine how patient services team members are interacting with patients and healthcare professionals. Do various team members have call or meeting targets? Are Hub coordinators given company-approved call scripts? Are the call scripts appropriate or should call guides be provided? Which team members can assist patients with reimbursement information and directions? Similar to the controls companies put into place when outsourcing activities to third-party vendors when interacting with healthcare professionals, it is imperative that there are comprehensive and adequate controls in place to mitigate any potential risks between the vendors and the patients. These controls must also be applied to internal team members’ processes and activities.
Patient health information
As the interactions between companies and patients are increasing, access to and sharing of PHI are areas that must be scrutinized. What elements of patient information are being shared with whom, not only within the patient services team but also across various functional areas in the company? Companies may need to consider the implementation of a data privacy management program, enhanced by technical considerations and overall decisions, as well as training components and strict supporting documentation.
Similar to monitoring and auditing programs created to address compliance adherence in their sales force, 59% of companies surveyed stated that they are starting to audit and monitor the activities of various patient services functions, such as patient educators and case managers. Companies are also introducing advanced analytics and technology platforms within programs to proactively manage and avoid compliance risks. They are creating requirements for advanced compliance programs utilizing analytics, and automating audits and reviews of calls utilizing next-generation digital methods, such as voice-to-text technology.
A well-run patient services program that can provide effective disease education and financial support to patients could potentially be lifechanging for many patients. However, with so many patient needs, many unanswered compliance and legal questions, and the increasing scrutiny into this area, companies must ensure their programs are effective for the patients while simultaneously mitigating their ongoing risks.
- The OIG guidance states “Pharmaceutical manufacturers offer copayment coupons to insured patients to reduce or eliminate the cost of their out-of-pocket copayments for specific brand-name drugs. These coupons constitute remuneration offered to consumers to induce the purchase of specific items” (https://oig.hhs.gov/fraud/docs/alertsandbulletins/2014/SAB_Copayment_Coupons.pdf)
- U.S. Department of Health and Human Services Food & Drug Administration (FDA) January 2017 memo Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products http://www.ascrs.org/sites/default/files/FDA_Memorandum–Public_Health_Interests_and_First_Amendment_Considerations_Related_to_Manufacturer_Communications_Regarding_Unapproved_Uses_of_Approved_or_Cleared_Medical_Products_Jan_2017%20%281%29.pdf
- FDA’s January 2017 Draft Guidance Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers
ABOUT THE AUTHORS
Marci Juneau is a partner at Helio Health Group and is based out of Atlanta, GA. Prior to Helio, Marci was director at Huron Consulting Group’s Life Sciences Practice and worked for Ernst & Young’s Fraud, Investigation and Dispute Services, focusing on healthcare. Marci has an MBA from Georgia Institute of Technology and a BS in Engineering Science and Economics from Vanderbilt University.
Minna Bak is a senior manager at Helio Health Group and is based out of the New York, NY office. Prior to Helio, Minna worked at Acquis Consulting Group and Huron Consulting Group’s Life Sciences Practice. Minna has an MBA from New York University and a BS in Bioengineering from the University of Pennsylvania.