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Expertise

Dr. Richard Stefanacci

Chief Medical Director

Expertise:

Affordability Programs (PAP, Copay), Neurology/CNS, Pricing, Reimbursement & Market Access, Stakeholder Engagement & Promotion (Patients, Payers, Providers)

Richard has focused his career on improving health outcomes, especially for some of the most vulnerable populations. This has been achieved through several avenues, beginning with his continued active role as a treating internist/geriatrician. He has also put this focus into practice as chief medical officer for several management care plans, including ElderHealth/Bravo/HealthSpring/Cigna and PACE (Program for All-inclusive Care for the Elderly) programs, as well as his current role as a pharmacy and therapeutics committee member for several national plans. On the policy side, Richard served as health policy scholar for the Centers for Medicare & Medicaid Services (CMS) through his role at Thomas Jefferson University, College of Population Health, where he maintains a faculty appointment. He has over 500 publications in addition to delivering well over 1,000 lectures, both nationally and internationally, focused on improving health outcomes. Today, Richard is actively engaged in leading population health activities for numerous health systems and payer groups.

His recognized expertise has led to Richard being appointed to serve on the American Society of Consultant Pharmacists (ASCP) and the AMDA Foundation boards, as well as being an honorary lifetime member of the ASCP and the National Association of Directors of Nursing. Richard has achieved recognition as a fellow in both the College of Physicians of Philadelphia and the American Geriatric Society and was recently awarded the Humanism in Aging Leadership Award from the University of New England.

Richard’s work for vulnerable populations is very personal, stemming from his involvement with the Go4theGoal Foundation (www.Go4theGoal.org), a 501(c)(3) public charity that he founded with his family and friends when his oldest son, Richard, was diagnosed with Ewing’s sarcoma. Since its inception, the foundation has raised several million dollars to assist hundreds of children affected by cancer at nearly 100 children’s hospitals across the country while also funding cutting-edge research to find a cure. This research work is directed by the foundation’s panel of experts, which includes several current and past federal government leaders in rare diseases.

Richard holds a DO and an MS in geriatric healthcare from the A.T. Still University of Health Sciences, as well as an MBA from the Keller Graduate School of Management of DeVry University. He is also an American Geriatrics Society Fellow and a certified medical dosimetrist.

Articles by Dr. Richard Stefanacci

BLOG: Segmenting Health Systems

The COVID-19 pandemic has separated health systems based on the impact of the pandemic on their staff, operations and finances. While many health systems have struggled in these areas, some have truly succeeded. This means that stakeholders developing relationships with health systems to improve outcomes must do so through the use of their specific pharmaceutical treatments. Demonstrating a clear appreciation of the priorities, abilities and focus of a treatment is essential and is not a one-size-fits-all situation. Even prior to COVID, a health system’s priorities could be assessed through their County Health Ranking and Community Health Needs Assessment (CHNA). The CHNA is required for all nonprofit health systems every three […]

Promoting Treatment of the ‘Right’ Patient

Every treatment has a patient population that truly benefits from the intervention. This population starts with those targeted in the pivotal trials but typically grows from there based on real-world evidence (RWE) and prescriber experiences. At the other end of the spectrum from patients who benefit are those who have dissatisfying outcomes from the same treatment. The most obvious are those called out as contraindicated on the FDA label; but there are, of course, individual patients for whom the benefits of treatment are outweighed by costs based on genetics, drug interactions, disease states, history or care goals. Failure to appreciate this range and instead viewing patients as all the same […]

BLOG: Moving to More Comprehensive HEOR Data

Health economics and outcomes research (HEOR) by definition is a discipline that is used to complement traditional clinical development information (i.e., efficacy, safety, quality) to guide patient access decision-makers to specific drugs and services. The foundation of HEOR is typically set by the finances that managed care payers are responsible for. This limits assessment to financial considerations, such as hospitalizations, medical procedures and treatments. Those elements covered under the Medicare Parts A, B and D and by Medicare Part C (Medicare Advantage plans) represent only 39% of the Medicare market. While finance is most often the focus, it does not get to the priorities of the majority of prescription drug payers […]

BLOG: Targeting the ‘Right’ Patient — How Pharmaceutical Companies Can Help Physicians Connect Patients to the Right Treatments

Not every drug is right for every patient, but for some — or the “right” patient — treatment can provide significant clinical and financial benefits. For new therapies, identification of the right patient can be a challenging journey. This journey is best started by first targeting the most appropriate patients while additional evidence is developed for expanding that reach of HCPs through extending their comfort to a wider range of patients. Unfortunately, it is becoming increasingly common for groups to simply view medications as “good” or “bad” for all patients. The headlines out of the latest Institute of Clinical and Economic Review (ICER) meeting on Biogen’s Aduhelm for Alzheimer’s disease […]

BLOG: Medication Adherence Opportunities and Challenges

“Drugs don’t work in patients who don’t take them.” − Former U.S. Surgeon General C. Everett Coop While it seems obvious, the amount of attention given to adherence is extremely low, especially in comparison to the high costs associated with non-adherence. A recent review published in the Annals of Internal Medicine estimated that a lack of adherence causes nearly 125,000 deaths, 10% of hospitalizations and between $100–$289 billion a year in healthcare costs. Yet we focus more attention on patient diagnosis than on adherence once treatment orders have been established. Addressing adherence begins with improving patients’ and their caregiver’s perception of the value of each medication prescribed. It has been said that the primary driver of […]

BLOG: ‘Bundling’ Payments to Assure Appropriate Rx Use

In Medicare’s drive to improve outcomes of the fee-for-service (FFS) payment model, this model is being replaced with value-based care. The delivery of value-based care is not supported by FFS payments, which incentivize the volume of services delivered. Rather, value-based care is more aligned with a bundled payment model in which providers are directly held responsible for both clinical and financial outcomes of patient treatments. These bundled payment models run the gamut from full risk to episodic periods. These payment arrangements vary based on the following: Who is the patient population? When is the period of responsibility? What services is the payer or at-risk provider responsible for? How is the […]

BLOG: Pharmaceutical Value-based Contracts: Adherence and Supportive Contracts

While there is a great deal of talk regarding value-based contracts in the life sciences industry, there are few successful examples. The difficulties in structuring these contracts begin with identification of outcomes that are directly and primarily related to a specific treatment. In addition, these outcomes need to be readily and easily available to track. All too often there are external influencers impacting outcomes that are outside the effects of the pharmaceutical, such as social determinants of health or health system initiatives. One of the first pharmaceutical value-based contracts was established by Pfizer with the State of Florida Medicaid program more than 20 years ago. The arrangement promised to reach […]

BLOG: Medical vs. Pharmacy Benefit: A Look at UM Differences

Medicare medical and pharmacy benefits are very different in their utilization management (UM). As such, it is valuable to know the distinctions between benefits, as strategies differ depending on which ones apply. The most significant differentiator is the fact that utilization is typically greater under the medical benefit, as Medicare does not do any prior utilization management. Rather, physicians can prescribe any medical benefit, including off-label use. The only prospective review the Centers for Medicare and Medicaid Services (CMS) provides is in the form of guidance through Local or National Coverage Determinations, although this is rarely used. Even less used is CMS retrospective review through claims or chart reviews to […]

BLOG: Gaining Coverage for Emerging Medical Technologies

The line between medical and personal care is everchanging. In all areas of our lives there is coverage through medical benefits, but the exact line between this and one’s personal responsibilities is not always as clear, and it is evolving. Whether it be transportation, housing or food, medical coverage is provided. Although not always considered, transportation, for example, is provided for emergency care; but increasingly, providers are covering transportation for routine appointments as well. Transportation is even being provided for grocery store runs. The reason is that as providers increasingly take on risk for clinical and financial outcomes, they realize that providing coverage for these services can improve their healthcare […]

Navigating Payer Formularies and Meeting Payer Needs — and Why It Matters

In a market where all healthcare stakeholders expect more from manufacturers, payers are no exception. As payers work to support patients and meet their own industry needs, manufacturers need to understand payer processes to improve patient treatment access. To start, payers have lists of covered drug products called “formularies.” These lists are organized by products preferred by payers or products discouraged by payers. Payers will go a step further by dividing outpatient therapies on formularies into three to five “tiers,” each with a different level of patient cost-sharing. Formulary selection involves an assessment of a product’s clinical performance and relative cost. With formularies, payers have substantial leverage to provide purchasers […]

Pharmaceutical Opportunities and Challenges Facing Long-Term Care Facilities

Skilled nursing facilities (SNF) and long-term care (LTC) facilities have been a major source for news stories throughout the COVID-19 pandemic due to the devastation brought to patient populations. Now, pharmaceutical manufacturers have an opportunity to support these facilities and patients that companies may not have considered before. As an LTC facility owner/operator, medical director and attending physician, I have seen firsthand the opportunities and challenges for pharma in long-term care. The Current Situation: Patients in LTC facilities often have high drug utilization. In almost 16,000 facilities with 1.7M beds serving 1.3M residents, the majority of patients are dual eligible (covered by both Medicare and Medicaid). These beneficiaries pay $0 […]

BLOG: The ABCDs of Medicare Drug Coverage

The Medicare benefit is divided into four parts, each providing a unique drug benefit. Together, the four parts provide medication coverage – from oral medications taken at home to IV treatments given in a physician’s office to all medication provided during a hospital stay. Of course, many coverage details are in a constant state of flux, affecting exactly how coverage is provided. This article describes each part of Medicare with key coverage details and outlines how pharmaceutical manufacturers need to navigate each part of the ABDCs of Medicare to assure access and utilization for Medicare beneficiaries. Medicare Part A The ABDCs of Medicare drug coverage begin with Medicare Part A, […]

BLOG: Not So Rare… The True Impact of Rare Diseases

Rare disease treatments seem to be everywhere today. This is true despite the fact that to be considered a rare disease, fewer than 200,000 patients are affected — and for ultra-rare, fewer than 7,000 patients are affected. This definition was created by Congress in the Orphan Drug Act of 1983. Rare diseases became known as orphan diseases because drug companies were not interested in adopting them to develop treatments. The Orphan Drug Act created financial incentives to encourage companies to develop new drugs for rare diseases. The rare disease definition was needed to establish which conditions would qualify for the new incentive programs.  That means a 1M–member plan is likely to have only one rare disease patient, and a primary care provider with only 2,500 patients is unlikely to see even one over their career. As such, rare has rarely been on anyone’s radar; although when […]

BLOG: Population Health Leadership

“Population health” is the result of pushing health systems to be clinically and financially responsible for their communities. This is a significant shift from simply being focused on the volume of services delivered within the hospital.  The focus on population health represents a movement for pharma from the past (targeting physicians due to their control of prescriptions) to managed care organizations during the heydays of HMOs to our current time of health system domination of the control of therapy selection. Each of these treatment controls focused on a different element of the Triple Aim: from patient care to cost to the current focus on population health.  As health systems become more prevalent, they are having increasing levels of control over treatment decisions, in coordination with physicians and managed care organizations. As a result of this increased level of […]

BLOG: “Payvider” Growth Continues — But Not From the Payers

“Payviders” is the term used to describe the coming together of both payers and providers. In the past several years this has been driven primarily by provider consolidation. As these providers have grown into large, sophisticated groups or wind up under health systems, they seek out risk — serving the role of the payer as well — through becoming a payvider.  But those same factors that have pushed providers to take risk are shifting. As a result, the growth of providers taking risk will surely decline in the coming years. These include factors such as the new Secretary of Health and Human Service Xavier Becerra’s deep belief that big is bad. We saw this in his suit against Sutter Health. When Becerra was attorney general of California in 2018, he sued Sutter Health on allegations that Sutter made multiple acquisitions […]

Under the Biden Team & Beyond COVID … What Lies Ahead for Healthcare

While the obvious healthcare focus for the new Biden/Harris Administration will be on controlling the COVID-19 pandemic, it’s a critical time to assess what lies beyond COVID for their attention. To gain a sense of what’s to come — like assessing the future season for your favorite sports team — one starts with who makes up that team, what their strengths and weakness are and where they historically have been focused. The nominee to lead the Department of Health and Human Services, Xavier Becerra, is the former attorney general for the State of California. As an attorney Becerra has a keen focus on the law and applying it to meet […]

Approaching Clinical Pathway Development as an Art

Much like any artform, creating a clinical pathway requires forethought, innovative design and strategic execution in the hands of the physician — except in the art of healthcare, the most important critic is the patient. While physicians try to perfect the art of patient care, the market realities of sky-rocketing costs and fewer resources influence how their practices are managed. Following a fee-for-service care model often dulls the character and priorities of a practice while pushing the needs of patients to the back burner. Instead, developing clinical pathways that align with value-based care allows for consistent, high-quality care that does not impede on the individual physician’s art of healthcare. Implementing […]

Impact of COVID-19 on the Quadruple Aim

COVID-19 has transformed the practices of healthcare professionals as well as the patient journey, leaving lasting impacts on the Quadruple Aim — cost, patient experience, population health and healthcare provider (HCP)/staff support. As independent, private medical groups have seen a 60% decrease in patient volume through the COVID-19 outbreak, physicians are moving their practices to payer or health system models. Health systems deliver patient care as “payviders,” the combination of a payer and a provider, while also serving as the center of delivery for the Quadruple Aim. Payviders may become the central model for care delivery post-COVID-19 as financial gain encourages health systems to shift from volume to value-based care. […]

Population Health Partnerships To Advance Value-Based Care

The business model for health care in the United States is evolving from a volume-driven model to a consumer-centric, value-driven model. As such, there are new competencies required of hospitals and health systems to effectively manage a population’s health across the continuum of care. Many hospitals and health systems will need to partner with other organizations to gain the capabilities and efficiencies required to provide services under new care delivery and payment arrangements. This article discusses the why, what and how of creating and implementing a population health project with partners. Download the FULL article HERE

CMS Proposed Medicaid Rule: Best Price Impacts of Value-Based Purchasing, Co-Pay Assistance Programs, and More

On June 17, 2020, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule outlining nine specific changes to Medicaid regulations. Five of these directly affect manufacturers through changes in administration of the Medicaid Drug Rebate Program (MDRP): Value-based Purchasing Arrangements Line Extensions Patient Assistance Programs MDRP Definition Clarifications Authorized Generics Download EVERSANA’s new report to learn how pharma manufacturers will be directly affected by the proposed “best price” rule and its impact on value-based purchases. How We Can Help As the complex pharmaceuticals regulatory framework changes at a breathtaking pace, EVERSANA helps you respond quickly and adapt to government pricing processes without sacrificing competitive advantage. Click here […]

Where Health Systems are in the Shift to Value: Four Categories

One could make the argument that there are four situational categories under which all health systems now fall on the journey toward more value-based care and away from the fee-for-service model. Assisting health systems in successfully transitioning to value-based care and delivering improved clinical and financial outcomes for their patient populations depends on very different approaches depending on where they fall on the spectrum. Appreciating these differences is critical to understanding how to approach each group of health systems when articulating value to achieve high-quality clinical and financial outcomes. Health systems are at varying stages and levels of focus when it comes to shifting their care delivery to a model […]

How COVID-19 will Change the Patient Journey, Reimbursement, and Care Delivery

Value-based care has led to much change in healthcare over the years, and COVID-19 is pushing change faster and even further. These changes forced by COVID-19 will have long-term effects on every aspect of care delivery; current healthcare tools and programs such as clinical pathways need to adjust to these changes to continue being helpful. Current shifts provide new opportunities with greater urgency for further change to aid in the evolution of the healthcare system. COVID-19, with its stay-at-home requirements and restrictions on face-to-face interactions, has changed how care is delivered, and these changes will remain beyond this crisis. Indeed, actions by and learnings for all stakeholders (i.e., patients, payers, […]

Oncolytic Biosimilars: An Opportunity to Reduce Oncology Treatment Costs

Inclusion of oncology biosimilars in clinical pathways is one approach to reducing costs in this therapeutic area without compromising outcomes for cancer patients. There are currently eight Food and Drug Administration (FDA)-approved oncolytic biosimilars in the US market. Patients, providers, payers, policymakers, and manufacturers are all stakeholders that will be affected by these new biosimilars—and they all influence the placement of biosimilars in clinical pathways to ensure their appropriate use. Oncolytic biosimilars have the potential to save the healthcare system billions of dollars each year as more biologics lose exclusivity. In this white paper, EVERSANA experts explore the biosimilar market implications for each stakeholder and how to ensure this cost […]

Proactive Steps to Ensure Appropriate Utilization of the First Disease-Modifying Therapy for Alzheimer Disease

Widespread hope exists that aducanumab will soon gain Food and Drug Administration approval as the first disease-modifying therapy for patients with mild cognitive impairment associated with Alzheimer disease (AD), which could significantly impact the management of AD. If approved, challenges need to be addressed to properly identify patients who will benefit from treatment and ensure access. EVERSANA experts provide recommendations for proactive steps for key stakeholders – patients, providers, health systems, CMS services, and payers – on where pathways can help to ensure that all aspects of the Quadruple Aim—individual patient experience, population health, cost of care, and caregiver support—are addressed. Attainment of each of these aims is only possible […]

Clinical Pathways and Policy to Guard Against Misaligned Incentives

The application of clinical pathways and their enforcement through quality metric benchmark setting and appropriate use criteria is needed to guard against perverse financial incentives that encourage overutilization and underutilization. Moving forward, the more diligent payers and integrated delivery networks can be in evaluating and incorporating utilization criteria when establishing clinical pathways, the better off our system will be. Our experts explore different payer policies and market dynamics that can result in the overutilization or underutilization of healthcare treatments. They also explore opportunities to mitigate the unintended consequences of previous policies, both through new Centers for Medicare & Medicaid Services (CMS) policy efforts and clinical pathway application. Because most spending […]

Oncology Treatment Access in 2020 and Beyond

2020 promises to be eye-opening as the coming election will surely provide clarity to the path that we will be taking for oncology treatment access. From international reference pricing, acceleration of biosimilars and generics, and allowance of reimportation – pressure continues to mount to reduce pharmaceutical prices, especially those used to treat cancer. Much of the year will be focused on aligning misaligned incentives. Even now there are several proposals that could form the foundation for this future landscape impacting oncology treatment access. Pressures on pricing and access for oncology treatments will increase in 2020. Winners in this space will be those that articulate their value to key stakeholders and […]

Alexa, Can You Transform Healthcare?

“Alexa…,” “Hey Siri…,” “OK Google…,” “Hey Cortana…,” and “Hi Bixby….” These are the now-familiar “wake words” that we use to interact with our digital assistants and an ever-growing number of smart speakers. Chances are you have even interacted with one or more of these devices today. According to Allied Market Research, the smart speaker market is expected to reach $23.3 billion by 2025. A recent report states that last year’s smart speaker shipments reached 92 million. Speech is one of the things that makes us human, and for most of us, our voices are our primary method of communication. In healthcare, we use our voices to describe our symptoms, ask questions, and seek […]

Federal Enforcement of Clinical Pathways Resource Utilization Management

Providers order unnecessary tests for a variety of reasons: pressure from patients, fears of malpractice suit, not being knowledgeable about current “best” practices as well as for potential financial advantage for them or their health system. Clinical pathways built on solid clinical guidelines have the potential to lower costs through reduced resource utilization of potentially, unnecessary screenings, tests, and procedures. But clinical pathways are not effective if not implemented. Formal mandate of clinical pathways may be on the horizon, but enforcement has been historically slow in this sector of care. In the September Journal of Clinical Pathways article, EVERSANA’s Richard Stefanacci details the impact on patients and healthcare costs by […]

Ramifications of “Medicare for All” and Implications for Clinical Pathways

As the Medicare for All (M4A) debate continues into 2020, clinical pathway organizations, payers, health systems, providers, and patients will all play a role in shaping future policies around patient access and reimbursement. While it is certain that clinical pathways are shaping and will continue to shape health care regardless of system, what is far from certain is who the primary pathway developers will be and how the pathways will be utilized. Also uncertain is what impact a M4A system would have on access for new innovative therapies, both in terms of development and for access to these therapies once they are available. Dr. Stefanacci and Matthew Pakizegee share insight […]

Balancing Access

Value propositions need to justify product pricing by focusing on the burden of severe illnesses and how the products address unmet needs.

Could CMS Policies Impact Investments in CAR T-cell Therapies and Other Innovative Treatments?

Clinical pathways that include CAR T-cell therapy as an option must integrate appropriate guidance on its use and settings of care.

Pathways for Paying for Rare Disease Treatments

This article was written for the Journal of Clinical Pathways Determining how to pay for the treatment of uncommon yet serious diseases is an important consideration in terms of sustainability and patient access. Novel and expensive therapies will create financial pressure for payers’ drug budgets. Clinical pathways have demonstrated success at determining the “right treatment for the right patient at the right time,” but they also have the potential to be used to provide guidance on the “right” payment path or alternative payment models to ensure access and to decrease financial burdens for patients and strain on payers and providers.

CMO Perspective on World without Medicare Rebates

Written for Med Ad News Magazine by Dr. Richard Stefanacci For chief medical officers (MO) of health systems, a world without Medicare rebates complicates the selection of a preferred treatment while also opening opportunities for improved clinical and financial outcomes. This is the result of Medicare rebates being eliminated, potentially being replaced by patient assistance programs (PAP) and greater use of “beyond the pill” programs that provide services directly to patients. This world without pharma rebates will force treatment differentiation on the basis of factors beyond rebate pricing to include “beyond the pill” offerings. Read the full article on the Med Ad News magazine website.

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How the Proposed Elimination of Medicare Rebates Would Impact Clinical Pathways

Government, Policy & Systems Changes Affecting Clinical Pathways This article is written by Dr. Richard Stefanacci, for Clinical Pathways Magazine. The Centers for Medicare & Medicaid Services (CMS) has published a range of new proposed and final rules regarding payment rates and policies affecting providers, payers, and patients. The Trump administration has also laid out a plan aiming to promote better competition and negotiation of drug prices. One proposed change is to eliminate pharmaceutical rebates in the Medicare system and potentially replace them with pharmaceutical patient assistance programs, ultimately impacting drugs’ formulary placement. As a result, health systems will need assistance when assessing the value of drug treatments. Clinical pathways […]

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