Evolving patient support services in the era of healthcare reform (part one)

In this first portion of a three-part series, Tracy Foster, President of Lash Group; and Stacie Heller, Vice President, Health Policy of Xcenda outline new barriers in light of the implementation of the Affordable Care Act (ACA) and explore the impact on insurance access, coverage and affordability.

Part 1: changes in insurance access, coverage and affordability

With President Obama’s second term now underway, the implementation of the Affordable Care Act (ACA) is officially moving forward. With that, one of the key pillars of healthcare reform – simply termed “coverage expansion” – will swing into action over the course of the next year. This initiative includes the establishment of state and federal health insurance exchanges and Medicaid expansion that, over time, could convert 25-30 million uninsured Americans into a “covered” situation. Despite the reform law’s expanded access provisions, however, there are still barriers to overcome – specifically related to three key trends:

1. changes in insurance access, coverage and affordability;

2. personalized medicine and diagnostics; and

3. shifting technology paradigms.

These trends are emerging due to evolving traditional access program models as our healthcare system moves into a new era.

While the full scope of expanded access is still out of focus, the need for continued patient support services is clear. The ACA’s “hallmark” expanded-access provisions are largely being implemented at the local level, creating a blurred approach to coverage in 2014 and beyond. As a result, manufacturers must take steps to ensure they are prepared to support providers, payers and new patient populations as key pieces of health reform come into focus.

“The ACA’s “hallmark” expanded-access provisions are largely being implemented at the local level, creating a blurred approach to coverage in 2014 and beyond.”


Changes in insurance access, coverage and affordability

Today, patients get less insurance coverage for their premium dollar. The number of plans with deductibles and with four or more cost-sharing tiers continues to rise. In addition, the out-of-pocket cost-share for specialty drugs continues to increase.

With healthcare reform the Congressional Budget Office (CBO) estimates that 30 million fewer people will be uninsured in 2020. While the ACA’s expanded-access provisions will be in place starting in 2014, the full effects of health reform will take shape over time. By 2020:

• Medicaid / CHIP enrollment is expected to expand to 11 million more Americans;

• an estimated 26 million Americans will receive their insurance through exchanges; and

• employer-sponsored insurance will remain the dominant source of coverage but is expected to be offered to four million fewer individuals as the ACA’s coverage expansion provisions are implemented.

With an increased number of patients eligible for minimum essential coverage through the Medicaid expansion or subsidized coverage through the state insurance exchanges,managing costs will become even more important to health plans administering the comprehensive benefits package to the expanded population. As a result, payers are planning for restrictions on expensive medications in an effort to control costs.

As Medicaid expansion was deemed optional by the US Supreme Court’s decision last June, to date, fewer than half the states have opted to expand to the new eligibility criteria. Because of this, there will continue to be considerable variation in eligibility, coverage parameters, and benefits available to the low-income population. The outcome is that millions of Americans living in states that refuse Medicaid expansion will remain uninsured – which means the poorest will not be able to get insurance despite the ACA’s expanded access provisions. Moreover, state discretion with regards to essential health benefits benchmark plan selection will also result in considerable variation in the scope of product coverage. As a result, it will be increasingly important for physicians to understand the various coverage sources of the newly insured from the standpoint of scope of benefits covered, out of pocket exposure to the patient amidst an environment further challenged by payment reforms.

Open enrollment for the new coverage sources begins October 1, 2013, so manufacturers should be underway in planning and configuring their programs to maximize the access opportunities for patients they currently support with free medications, and assessing current co-pay strategies in order to prepare for the adjustments that will come with the new healthcare landscape. With many millions of Americans gaining insurance under the ACA, it’s anticipated that the challenge of affordability with out-of-pocket costs (i.e., co-payments, co-insurance, etc.) will rise significantly.

“Today, patients get less insurance coverage for their premium dollar.”

Today, manufacturers often employ a three-pronged approach, utilizing a mixture of strategies to help underinsured patients receive appropriate access to medications:

• Commercial co-pay assistance

• Independent co-pay charities

• Expanded patient assistance or free drug programs

The variability across the states vis-à-vis Medicaid expansion, different approaches to state health insurance exchange models, and coverage profiles point to a continued level of uninsured and an increasingly significant cohort of underinsured individuals in 2014, and beyond. As such, critical and dynamic analyses are required to forecast the continued need for patient access services in the post-reform era. Analysis suggests that upon implementation of expanded access provisions in 2014, 80 percent of the uninsured population will remain uninsured in 2013, but that will decrease to 67 percent by 2015. By 2015, the Congressional Budget Office (CBO) estimates that an additional 12 million people will be enrolled in Medicaid and the Children’s Health Insurance Program (CHIP), and 13 million people will be enrolled in health insurance exchanges. As a result, there are four key tasks manufacturers must undertake to ensure 2014 readiness:

Assess / understand how states are implementing the ACA’s expanded-access provisions to inform patient transition strategy

During the time of expansion, patient assistance programs and reimbursement support services will provide valuable education support for patients who need to understand how to access their new insurance options. Because of this, it’s critical for manufacturers to create specific strategies that take into account their company’s product type and the disease state it treats. Establishing and administering co-pay programs is a good example as historically, participating rates in co-pay programs have indicated that large numbers of patients are not taking advantage of these programs as much as they could. It’s essential to build awareness for these programs. It’s important that patients needing this type of support know these programs exist and have a firm grasp on how to participate in order to ensure uninterrupted access to care and medications.

Model current and projected patient population needs

Programs that provide wrap-around, fully integrated services to patients, as well as to physicians and their staffs, will have the most impact. To maximize patient uptake and ongoing adherence, a program should offer all of the access services a patient might need in one place – from reimbursement support and co-pay assistance, to patient assistance and adherence services.

“…the poorest will not be able to get insurance despite the ACA’s expanded access provisions…”


Develop new policies, procedures and associated communications plan

Manufacturers will need to work closely with physicians and pharmacists to maximize program awareness. Physicians and pharmacists are used to visiting product websites to identify support programs, so manufacturers should use their websites as a resource for providers to find product and access information. Webcasts and field force personnel like reimbursement managers can also be used to get the word out, as well as partnerships with state societies and physician networks within a particular disease state.

Determine and develop transition support to help patients navigate new sources of coverage

Although evolving, patient assistance programs will continue to be a critical support offering in the post-reform era. Because of the ACA’s promise of expanded access, a common misperception is that patient assistance programs will no longer be needed. After what is expected to be a protracted transition to new coverage sources, there will still be an estimated 20 million uninsured individuals who may need support through these programs.

“…patient assistance programs will continue to be a critical support offering in the post-reform era.”


Through patient segmentation analyses, manufacturers can assess and plan for their new patient assistance program approach within the new world of the ACA. Although many of the existing patients will be transitioning to coverage, the remaining patients in need will present challenges because many of them tend to be very transient in nature. Additionally, a significant portion of the remaining uninsured will be undocumented, so manufacturers should assess their eligibility policies as it relates to citizenship and assess their operational procedures as it relates to having bilingual materials and agents to support this population.

These strategies will certainly continue to apply within the evolving health reform landscape, but the mechanisms to provide assistance, the scale of assistance required, and the patient mix seeking assistance will change. Manufacturers should assess their patient populations to understand the potential shift in resources required to support the underinsured as patients transition to new sources of coverage.


1. Congressional Budget Office (CBO); Effects of the Affordable Care Act on Health Insurance Coverage—February 2013 Baseline. http://www.cbo.gov/publication/43900.

View the next article in this series here



About the authors:

Stacie Heller

Vice President, Xcenda

Stacie Heller brings twenty years of experience to her role as Vice President of Xcenda’s Health Policy consulting practice. Based in Washington DC, Heller leads a team of consultants from across the country who develop reimbursement launch strategies and guide clients through complex decisions related to coverage, coding, compendia, health policy / healthcare reform implementation, and the design of patient and provider support services.

Heller has in-depth knowledge of healthcare reform implementation, including guidelines on Accountable Care Organizations. As the editor of Health Policy Weekly, a complimentary e-publication, Heller keeps clients and stakeholders informed on the latest legislative and regulatory updates. Heller and her team track and analyze congressional and regulatory health policy and provide manufacturers and other stakeholders with ongoing strategic guidance, proactive updates, analysis and policy briefs related to issues affecting the healthcare industry.

Heller’s expertise encompasses a wide range of public payers and includes developing reimbursement strategies for new products and addressing reimbursement obstacles for existing therapies. Previously, Heller directed the operational management of the reimbursement-based patient assistance programs for HIV / AIDS therapies at the Lash Group. Before joining the Specialty Group, Heller monitored physician-related reimbursement issues for the American Society of Internal Medicine, now part of the American College of Physicians (ACP). Heller received a B.A. in public policy from Pennsylvania State University.

Tracy Foster, MBA

President, Lash Group

As President of Lash Group, Tracy Ott Foster contributes her expertise, strategy and experience to a company known for its unique patient and provider support programs. For over 20 years, Lash Group has designed, developed and implemented innovative programs within the pharmaceutical, biotech and medical device industries, creating solutions that help patients begin therapy in a timely manner while maximizing their ongoing continuity of care.

Under Foster’s executive leadership, Lash Group provides industry-leading access services from reimbursement strategy and support to copay and patient assistance solutions, and adherence and other clinical case management support services. Through these personalized and scalable support services, Lash Group enhances speed-to-therapy, promotes increased adherence and delivers actionable data to their partners. As part of AmerisourceBergen Consulting Services, Lash Group works to serve manufacturers with reimbursement services, patient advocacy programs, health outcomes and pharmacoeconomic consulting, advisory boards and payer-related analytics.

A respected speaker and insightful author of numerous trade articles, Foster’s influence on the pharmaceutical industry has spanned over 15 years. Her regular nationwide speaking engagements provide insights and strategic guidance on pertinent industry issues including product support programs, patient access, reimbursement policy and trends. Strategic planning, thought leadership and specialty pharmaceuticals continue to be passions for Foster, whose dedication and enthusiasm earned her accolades from the Charlotte Business Journal with a Top 25 Women in Business Achievement Award as well as a 40 under 40 Award.

How can we better support the health needs of the uninsured patient?