IfPA summits gather health policy stakeholders to debate, share, listen, learn and coalesce on the access issues that matter.

Seventh Annual Summit on Balanced Pain Management

What if all patients had a pain management approach that allowed them to live full and productive lives? That pivotal question resonated throughout the seventh Summit on Balanced Pain Management, a national policy event exploring patient-centered care for people living with pain.

Led by Mike Walsh of Alliance for Balanced Pain Management and Amanda Conschafter of the Alliance for Patient Access, the summit welcomed health care providers, policy experts, patient advocates and other stakeholders.

This year’s event, held virtually on February 2, 2021, examined:

  • Policy predictions for a new presidential administration
  • COVID-19’s impact on pain management
  • Utilization management barriers
  • Treatment challenges and osteoarthritis
  • Chronic pain and mental health.

Click below to read the report.


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National Policy & Advocacy Summit on Biologics

The fifth annual National Policy & Advocacy Summit on Biologics brought together health care providers, policy experts, patient advocates and other stakeholders. The event explored how sound public policies can facilitate the safe use of biologics in patient-centered care.

This year’s event, held virtually, examined issues such as:

  • What the 2020 election means for health care policy
  • Biologics’ role in treating cancer and migraine disease
  • The lasting impact of COVID-19 health policy flexibilities
  • Mental health and chronic disease
  • Biosimilars’ market uptake

Click below to read the report.


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Sixth Annual Infant Health Policy Summit

The sixth annual Infant Health Policy Summit welcomed health care providers, parents, policymakers, advocates and other stakeholders to explore how policy solutions can improve the health and lives of infants and their families. This year’s event, held virtually, examined issues such as:

  • Late preterm infants
  • Respiratory syncytial virus and COVID-19
  • Isolation and disruption during COVID-19
  • Vaccines
  • Disparities in infant health
  • Congenital gut disorders
  • Human milk.

The summit, which included a series of panel discussions, individual stories and interviews, was convened by the National Coalition for Infant Health and co-hosted by the Institute for Patient Access and Alliance for Patient Access. Read the report and watch the summit recording to learn more.

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Sixth Annual Summit on Balanced Pain Management

Pain is a single word with a thousand different meanings, as the sixth annual Summit on Balanced Pain Management made clear.  So if policymakers want to tackle America’s pain problem, they should begin by embracing individualized, patient-centered, care.

What does that look like?  Panelists and speakers at the day-long policy event in Washington, DC weighed in. 

Profiles in Pain

For patients, it may begin with having their pain understood by family, society – and even their physicians.  Through a series of “Profiles in Pain,” patients attested to how pain has shaped their lives. Shirley Kessel of Miles for Migraine described the intergenerational impact of migraine pain on her family.  Kessel recalled her mother withdrawing from the family for days with migraine attacks, which now prevent her two daughters from fulfilling their academic and professional potential.  

For Penny Cowan of the American Chronic Pain Foundation, debilitating pain became manageable only after receiving interdisciplinary care at an inpatient facility.  Cowan has since spent her life teaching others how to live with pain.

Pain also shaped the lives and careers of Dania Palanker, JD, of Georgetown Health Policy Institute and Kate Nicholson, JD, a civil rights attorney.  Nicholson was an attorney enforcing the Americans with Disabilities Act when a surgical injury initiated intense back pain.  She was forced to reconfigure her work through video conferencing and telecommuting.  

Palanker, meanwhile, fought fibromyalgia pain throughout law school.  She now dedicates her career to making insurance affordable and accessible to Americans from all walks of life.  When it comes to coverage for alternative pain care and integrative techniques, “we have a long way to go,” Palanker emphasized.

Access & Innovation in Pain Care

Panel discussions reinforced Palanker’s concern.   

Members of the Department of Health and Human Services’ Pain Management Best Practices Interagency Task Force have issued a “tour de force” report on policy solutions to America’s dual opioid and pain management crises, explained John Prunskis, MD, of the Illinois Pain Institute.  Cindy Steinberg of the U.S. Pain Foundation conveyed the report’s conclusion that “Best practice is a multimodal, multidisciplinary approach” with both pharmacologic and non-pharmacologic treatments.  But as Jianguo Cheng, MD, PhD, of the Cleveland Clinic explained, “If [multidisciplinary care is] not accessible, it’s meaningless.”

Continued innovation is also critical to making patient-centered pain care a reality.  In a panel discussion hosted by Peter Pitts of the Center for Medicine in the Public Interest, the Food and Drug Administration’s Douglas Throckmorton, MD, explained how the agency is working to tackle the challenges presented by pain care.  Leigh Callahan, PhD, of the Osteoarthritis Action Alliance emphasized the importance of clinical trials that gauge outcomes that matter to patients.  Patients want to be able to “pick up their grandchild, play golf,” Callahan explained.  

And Danielle Friend, PhD, of the trade group Biotechnology Innovation Organization noted that insurance coverage challenges can discourage innovation in new, opioid-alternative pain treatments.  “It’s hard to get investment,” Friend noted, “if people think they won’t be reimbursed.”

Coverage challenges also arose during a panel discussion on access to patient-centered care.  Matt Salo of the National Association of State Medicaid Directors noted that “there’s always a lag” between new approaches like integrative pain care and uptake.  Salo emphasized the need for more data demonstrating that integrative and multimodal pain approaches work for patients.  Ellen Blackwell, MSW, of the Centers for Medicare and Medicaid Services agreed, though she noted that some states have begun to “put their toes in the water” by providing coverage for alternative or non-pharmacologic treatments.

Ann Quinlan Colwell, PhD, RN, of the American Society for Pain Management Nursing emphasized the importance of a patient-centered approach, explaining that “each person feels pain differently and has a different ability to utilize different interventions and medications.”

Diverse Needs & Treatment Options 

Addressing the different facets of pain often requires a multi-prong approach.  In a panel discussion of integrative pain care, Mark Shepherd, PT, of Bellin College outlined the value of physical therapy.  “We should empower our patients, we should educate them, and we should teach them to move in a way that’s comfortable,” Shepherd explained.  Fellow panelist Greg Hobelmann, MD, of the Ashley Addiction Center noted the importance of emotional support and treatment for co-occurring psychological issues.   And moderator Paul Christo, MD, of Sirius XM Radio’s “Aches and Gains” highlighted the power of neuromodulation for treating pain.  Michael Leong, MD, of Stanford’s Pain Management Center agreed the technology could be “amazing,” especially for patients seeking non-opioid treatment options.

Meanwhile, a panel discussion of 2019 survey data underscored why patient-centered care is needed.  Monica Mallampalli, PhD, of HealthyWomen reported that the organization’s study revealed a majority of women saying pain stopped them from living a full and active life.  Brian Green of Health Union conveyed a key finding from a new study undertaken by Health Union and the U.S. Pain Foundation: patients in pain want a health care provider who uses a personalized, individualized approach and is willing to try alternative treatments.  The patients’ primary goal, Green explained, is to maintain quality of life, keeping pain at manageable levels so people can go about their daily lives.

Josie Cooper of the Alliance for Gout Awareness conveyed study findings on how stigma and misinformation complicate treatment for gout, a painful form of arthritis.  “Patients are self-treating and trying to do this on their own,” Cooper explained, “without consultation with a medical professional.” 

The day-long event made it clear that education and access to patient-centered pain care are challenges that require committed advocacy from patients and health care providers.  In closing remarks, Alliance for Patient Access National Chairman David Charles, MD, urged attendees to come together in the new year to advocate for policies that advance the approach.

The sixth annual Summit on Balanced Pain Management was convened by the Institute for Patient Access and hosted by the Alliance for Patient Access and the Alliance for Balanced Pain Management.  See highlights and videos from the day’s event using #SummitBPM2019.

Read the event report.

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Infant Summit 2019

As CNN anchor Alisyn Camerota remembers, it was just another day at work. Until it wasn’t.  A routine prenatal check-up for Alisyn, then 30 weeks pregnant with twins, turned life changing when her doctor announced that she’d need to deliver her daughters within 48 hours. A rare condition was preventing one baby from receiving enough nutrition through the umbilical cord.  

As Camerota explained during her keynote address at the fifth annual Infant Health Policy Summit, this was just one of the challenges she faced.  Before her pregnancy, Camerota had struggled with infertility. After her daughters were both safely delivered and in the NICU, she faced breastfeeding challenges.   

Camerota described attempting to pump breastmilk for days with no results.  When she told her doctor she was ready to give up, he advised, “Give it one more day.”  The next day, Camerota recalled, she produced her first drops of milk. The NICU nurses – “angels on Earth” – immediately put it into her newborn daughter’s feeding tube.  

Camerota’s experiences resonated with the advocates, clinicians, patients and policymakers attending the summit.  And the day’s lineup of interviews and panel discussions echoed themes from her story, especially the struggles and the triumphs of meeting infants’ needs. 

Breastfeeding & Human Milk

Describing the value of human milk as a “cornerstone issue” for the National Coalition for Infant Health, Medical Director Mitchell Goldstein, MD, moderated a discussion of how human milk benefits the human microbiome.  Human milk doesn’t just promote “good” gut bacteria but can reduce the risk in lower respiratory infections by 50%, explained Cynethia Bethel-Jaiteh, DNP, of the University of Louisville School of Nursing, and lower the risk of GI infections by 59%.  It can also reduce the risk of necrotizing enterocolitis, explained Victoria Niklas, MD, of Prolacta Bioscience.

Deb Discenza of PreemieWorld recalled her own challenges pumping breastmilk for her premature daughter, born at 30 weeks gestation, while the hospital intended to give her daughter formula. 

Vaccine Hesitancy

Incongruity between parents’ and health care providers’ intentions also came up during a panel discussion of preventable diseases and vaccine hesitancy in the United States.  Daniel Salmon, PhD, of Johns Hopkins School of Medicine and Mary Koslap-Petraco, DNP, of Stony Brook University School of Nursing debunked widespread myths that have led to a rise in vaccine exemptions – and fueled outbreaks of preventable diseases.  Topics included autism links, government overreach and misinformation about vaccine ingredients.  

Both Salmon and Koslap-Petraco emphasized the importance of empathizing with parents and educating about the potential impact of vaccine-preventable diseases like measles, rubella and hepatitis B.

NICU Disparities 

Good communication with parents of young children was also a central theme in a panel discussion about how to build patient-centered NICUs.  DeShay Rice-Clansy, MSW, of Atlanta’s Grady Health System and Brigit M. Carter, PhD, RN, of Duke University School of Nursing described how the different demographics being served by NICUs can present strikingly different needs.  One mother delivering her baby at Grady Hospital, Rice-Clansy recalled, had only a second-grade education.  Other families faced challenges as stark as homelessness, mental health issues, substance abuse and sex trafficking.  

These hospitals and their NICUs must meet families where they are, explained Suzanne Staebler, DNP, of Emory University.  That includes staffing the hospital with diverse health care providers. But that’s not always easy. As Bridget Carter, PhD, of Duke University School of Nursing explained, the rate of diverse providers is “phenomenally low.”  

Innovation for Neonates

Getting infants and their families what they need also requires effective public policies.  In an interview with Amy Akers of the National Perinatal Association, the FDA’s Susan McCune, MD, described the strides that research and regulatory policy have made for neonates.  She noted that safety efforts have come a long way, describing morphine-laced “syrup” promoted in the early 1900s for babies with colic or teething pains.  Legislative policies are increasingly designed to promote the development of drugs specifically tested and designed for infants, Dr. McCune explained. She noted the impact of bills like the “Best Pharmaceuticals for Children Act” in 2002, which incentivizes the development of drugs for infants.  

But the process is rife with challenges. Only about 40% of studies of pediatric drugs are successful, McCune noted.  She emphasized the role of partnership, encouraging nonprofits and other stakeholders to join alongside regulators and researchers to improve options for treating infants.    

Respiratory Care

Respiratory care is one area where continued policy progress is needed.  In a conversation with Ashley Darcy Mahoney, PhD, of The George Washington University School of Nursing, Donald Null, MD, of UC Davis Children’s Hospital, described the improvement he’s seen during the course of his career.  It can take “a long time” for advances to make their way through, Null noted, and even then, policy often lags behind.  

Erin Thatcher of PPROM Foundation knows that all too well.  The mother of fraternal twins born prematurely, Thatcher described the impact of respiratory syncytial virus on her daughter, now 7, who still battles asthma-like symptoms from the disease.  The effects of RSV “can last for years,” Dr. Null explained.     

The panel spoke to the Academy of American Pediatrics Committee on Infectious Disease guidelines from 2014 that effectively reduced the number of infants who receive RSV prophylaxis.  Of those guidelines, Thatcher noted, “I wish they’d look at long-term outcome…the policies are not taking into account what’s happening to families.” 

Tubing Safety & Maternal Nutrition

Infant health, safety and guidance also came to light in updates provided by National Coalition for Infant Health Executive Director Susan Hepworth.  On the topic of tubing and connector systems used in NICUs, Hepworth alluded to hospitals’ being pressured to incorporate a tubing connector system known as ENFit, which can present safety challenges for infants.  Hepworth emphasized the importance of thoughtful consideration by hospital systems and NICUs, which should make decisions based on what’s best for their patients.

Hepworth also addressed new guidelines on pregnant mothers and fish consumption.  Recently revised FDA advice could, Hepworth noted, “help pregnant women confidently add more seafood to their diet, with the goal to have pregnant women eat, on average, as much as 6 times more seafood than they currently do.” 

See footage of the event from Facebook Live and explore photos and online activity from the day using #InfantSummit19.

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Second Annual Cardiovascular Health Policy Summit

Sandeep Jauhar’s grandfather was sitting down to lunch with family when he crumpled to the floor.  Jeff Kwitowski’s father was on a routine bike ride. Cat Davis Ahmed’s father was enjoying a game of tennis.  And Florence Champagne was in an office building when she dropped to her knees, gasping for air and praying for her life.

“The heart is the only organ that can kill you in a matter of minutes,” explained Dr. Jauhar, cardiologist, author and keynote speaker at the second annual Cardiovascular Health Policy Summit.  Speakers’ recollections of family tragedy and near-death experiences gave credence to his comment. They also attached a sense of urgency to the day-long event’s message: Heart patients need timely, affordable access to appropriate care and medicine.

In his opening remarks, former U.S. Surgeon General Kenneth Moritsugu, MD, emphasized this point.  “If we don’t have public policies that support and encourage access, we as health care professionals and advocates have failed our patients, and we will have failed our communities,” Dr. Moritsugu noted.  He implored the audience to “keep the patient at the center” of advocacy and health care.

But as the summit audience of health care providers, patients, Capitol Hill staff and other stakeholders came to understand, heart patients face a growing set of challenges.  

Rural Health Challenges

In a panel discussion titled, “Disparities in Rural America: Nurses’ View from the Front Lines,Martha Biddle, PhD, of the University of Kentucky College of Nursing explained that her typical patient faces multiple co-morbidities – “four-to-five active disease processes for most patients,” Biddle described.  

Rural isolation makes managing those conditions even harder.  Biddle described patients driving one-two hours to see a cardiology specialist.  And then there’s access to medicine itself. Eileen Handberg, PhD, of the University of Florida Health noted that some patients have 10 or more medications.  Even a modest co-pay, $5 or $10 per medicine, can become unmanageable for these patients given the number of drugs they take.  

Insurers’ prior authorizations can make access still more complicated.  Panel moderator Kim Newlin, MSN, of the Preventive Cardiovascular Nurses Association quipped, “I didn’t go to school and learn how to get prior authorization.” Eileen Handberg explained that the bureaucratic process is just another layer of complexity in patients’ attempt to access prescribed medicine.

Policymakers are working to address rural health challenges, explained Cara James, PhD, of the Centers for Medicare & Medicaid Services.  James described the agency’s efforts, which aim to improve the quality of rural health and the sustainability of rural hospital systems while also giving communities the autonomy to design a program that works best for them.

Access to Innovative Medicine

Rural or urban, patients who need innovative medicines like cholesterol-lowering PCSK9 inhibitors are fighting to get it – and not always with success.  In a panel discussion titled, “Access Anguish: When is Enough Enough?,” Keith Ferdinand, MD, of the Association of Black Cardiologists reflected on insurance denials for at-risk patients who had not responded adequately to statins.  It’s a “huge problem,” Dr. Ferdinand remarked, noting that for certain patients, “Just eating salmon and jogging ain’t going to do it.”

Delays in access can be dangerous, especially for patients who are born with a genetic predisposition to high cholesterol – a condition known as familial hypercholesterolemia, or FH.  The condition defies stereotypes about high cholesterol, afflicting people who are otherwise healthy and active. Few understand the irony as well as Jeff Kwitowski, an FH patient who saw his father die at age 60 from a heart attack.  “When I was 12 of 13, my cholesterol was already 400,” recalled Kwitowski, an avid runner. His daughter Cora also has inherited the disease and requires medication to lower her cholesterol.

Despite their risk, FH patients frequently face barriers to prescribed medicine.  So explained Cat Davis Ahmed of the FH Foundation.  Ahmed noted that 90% of FH patients go undiagnosed.  Those who do receive a diagnosis and are then prescribed a PCSK9 inhibitor are “at the finish line almost,” Ahmed described, “Then they’re denied.”

Harry Gewanter, MD, of the Alliance for Transparent & Affordable Prescriptions explained that the “extremely opaque, extremely complex” drug supply chain is part of the problem.  Pharmacy benefit managers, the middlemen who manage prescription drug benefits for major health plans, exacerbate the issue.  PBMs may make coverage decisions based on what’s financially advantageous to them through the drug rebate system – even if those decisions complicate access for patients at risk of heart attack, stroke or death.

And while insurers have argued that rejections occurred because physicians prescribed the drugs to the wrong patients, data show otherwise.  The Institute for Patient Access’ 2019 access report card reveals that even patients who have diagnosed FH, are already on a statin, or have already experienced a cardiovascular event are being denied at a rate of roughly one in three.

The issue came to a head recently when manufacturers of PCSK9 inhibitors slashed their prices by 60% — but patients saw no benefit.  Dr. Gewanter speculated that the lure of a lucrative rebate led PBMs to stick with the higher price tag rather than adjust to the new list price and lower patients’ out-of-pocket burden.

Comorbidities introduce another layer of complexity to access challenges.  Sarah Cassagrande, PhD, of Social & Scientific Systems, Inc. explained that the prevalence of diabetes has steadily risen in recent years, and people with diabetes having an increased risk of cardiovascular disease and stroke.  Despite their risk, however, more people are not getting the care they need, “missing important points of contact with physicians, which can result in more comorbidities.”  

Perhaps that’s because the burden of navigating the health care system’s complexities rests almost solely with the patient.  “You go to two different doctors, and you’re the person who has to coordinate,” explained Connie Newlon of WomenHeart, who at 47 years old has undergone quadruple bypass and continues to deal with a family history of heart disease as well as comorbid conditions. The frustration resonated with Jim Barton of Mended Hearts, who explained that his cardiologist felt pressed for time, further increasing the pressure on patient and provider alike.

Emotion, Stress & the Human Heart

The stress of getting cardiovascular care isn’t just irksome; it may also be unhealthy.  In his keynote address to the summit audience, New York Times bestselling author and cardiologist Sandeep Jauhar, MD, described the interconnection between the physiological heart and the metaphorical one.  Highly stressful events such as the loss of a spouse or sibling can actually trigger a physical change in the shape of the heart organ, Dr. Jauhar explained.  

Dr. Jauhar, himself a heart patient with a family history of cardiovascular events, explained that emotional well-being can influence heart health.  Research suggests that stress management may be even more strongly correlated with artery disease than exercise, Dr. Jauhar explained, while patients who are depressed after heart attack are more likely to die than those who are not.  “The emotional heart affects its biological counterpart in surprising and mysterious ways,” Dr. Jauhar summarized.

The Diabetes-Cardiovascular Connection

As the day’s final panel conveyed, at least one way to minimize stress for heart patients may be to offer a more holistic, team-based approach to caring for patients with both diabetes and cardiovascular disease.  “This is a huge issue, a multifaceted issue,” explained Alyssa Pressley, of the American Heart Association.  The organization recently launched a “Know Diabetes by Heart” campaign to raise awareness about the connection between the two conditions.  

Nancy D’Hondt, RPh, CDE, of the American Association of Diabetes Educators emphasized the importance of working to empower people with diabetes to better understand and manage their disease.  But for some regions this is a tall order.  Robin Diggs Outlaw, MPH, of the District of Columbia Department of Health described the “staggering” rates of diabetes seen in DC, where African American residents are three-four times more likely than other residents to have diabetes.

The group emphasized the value of evidence-based self-management programs, diabetes education, lifestyle changes for patients.  But they also noted the growing importance of medications that carry cardiovascular benefit in addition to treating diabetes.

The event closed with remarks from Nick Morse of the American College of Cardiology.  Morse reiterated the day’s themes of access and advocacy, urging participants to continue conveying the voice of patients to policymakers and to put the day’s sentiments into action. The second annual cardiovascular health policy summit was convened by the Institute for Patient Access and hosted by the Alliance for Patient Access and the Partnership to Advance Cardiovascular Health.  See more from the day’s proceedings with #CardioSummit2019.  

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Fourth Annual National Policy & Advocacy Summit on Biologics and Biosimilars

Languishing in a hospital bed after surgery for life-threatening Crohn’s disease, San Diego Chargers’ Rolf Benirschke, dangerously underweight and saddled with ostomy bags at only 24 years old, couldn’t see the value of going on.  But with top-notch medical care and the support of his family and teammates, Benirschke rallied. He ultimately returned to the NFL, where he played seven more seasons and was named NFL Man of the Year.  

His recovery story inspired attendees at this week’s fourth annual National Policy & Advocacy Summit on Biologics and Biosimilars, held in Washington, DC.  And it reinforced for the audience of health care providers, patients, advocates and policymakers the importance of access to innovative medicine.

Dubbed “The Value Proposition,” the event was convened by the Institute for Patient Access and co-hosted by the Alliance for Patient Access and the Biologics Prescribers Collaborative.  As AfPA Chairman David Charles, MD, outlined in his opening remarks, the organization envisions a patient-centered health care system that reveres the physician-patient relationship and holds access as the highest aim.  The result is better health outcomes, Dr. Charles explained, and eliminating avoidable costs to patients and the health care system. Dr. Charles acknowledged that vision as the organization’s ultimate “value proposition,” and the thematic framework of this year’s event.  

Diverse concepts of value unfolded during the day-long event.  

Uptake, Education & Non-Medical Switching

The value of innovative medicine and of choice among therapies emerged as a central theme.  In a panel discussion of biosimilar uptake, IQVIA’s Murray Aitken noted that the European Union has moved biosimilars to market more quickly than the United States has, resulting in more approved therapies.  But approval doesn’t equate to availability. Europe’s tender system, a winner-take-all approach to contracting between health care systems and drug manufacturers, can result in “forced switching issues” for patients, Aitken explained.

And forced switching doesn’t sit well with patients and health care providers.  As panelist Aline Charabaty, MD, of the American Gastroenterological Association noted, “Patients don’t want to change anything once they find the drug that works for them.”  Dr. Charabaty expressed physicians’ collective concern that patients could be switched without their physician’s knowledge or consent, and emphasized that biosimilar options were welcome as long as physicians retain control of treatment decisions.

Part of that control means having comprehensive data on biosimilars, a fact of which the Food and Drug Administration’s Sarah Ikenberry is keenly aware.  Recent FDA research revealed that physicians are focused on “what is the data, what are the approval standards, what is FDA looking at,” Ikenberry explained.

The panel, moderated by The Pink Sheet’s Nielsen Hobbs, agreed that the combination of education efforts, additional biosimilar approvals and a steady influx of peer-reviewed data would continue to build physician and patient confidence and increase treatment options.  

The topic of non-medical switching emerged again during AfPA Executive Director Brian Kennedy’s presentation of a recent AfPA study on the issue.  Describing switching as “penny-wise, pound foolish,” Kennedy explained how disruptions in treatment can drive up costs through hospitalizations, doctors visits and extra labs tests.  He also noted the far-reaching impact of switching on the lives of patients, who reported emotional stress, lagging productivity at work and the inability to handle caregiving responsibilities at home.

Overcoming Access Barriers

But non-medical switching isn’t the only access barrier facing patients and providers.  Insurers often hamper high-cost, high-value therapies like biologics with utilization management tools, seeking to curb costs by limiting patient access.  

In a panel discussion on talking with health plans, Ryan Gough of the Partnership to Advance Cardiovascular Health and Stacey Worthy of the Aimed Alliance conveyed their respective organizations’ efforts to improve patient access.  Gough described coupling data with patient testimonials to pressure insurers with high rates of rejection for heart patients prescribed cholesterol-lowering PCSK9 inhibitors.  

Worthy outlined her organization’s efforts at educating employers, the largest purchaser of health insurance, about the benefits of comprehensive coverage.  By outlining the benefits of access in terms of how employers can “increase productivity, decrease absenteeism, decrease medical expenses under health plan,” Worthy explained, employers are more willing to improve patient access.

Cost-Savings Proposals

Access issues also dominated the day’s final panel discussion, which explored proposals for reducing health care costs.  The Trump administration’s idea of shifting Medicare Part B drugs to Part D, the prescription drug plan, for instance is “one of those ideas people hoped has died on the vine,” explained Kevin Kirby of The Moran Company, “but is still in the president’s most recent budget proposal.”  As Madelaine Feldman, MD, president of the Coalition of State Rheumatology Organizations noted, some patients “can’t afford Part D” because it’s excluded from the supplemental Medicare coverage that patients use to access Part B medications.

The group also examined the Trump administration’s proposal for an international pricing index, which AfPA’s Gavin Clingham described as “one of the larger and more controversial” ideas put forth by the administration.  Panelists expressed concern with the scope of the project, which would affect 50 percent of Medicare providers, and impact patient access.

The cost-saving concept that most resonated with panelists and audience members was the administration’s recent proposal to end secretive rebate negotiations between pharmacy benefit managers and manufacturers in favor of direct-to-patient drug discounts.  “This would disrupt the entire system for Part D,” Dr. Feldman predicted, adding, “In three-to-five years this could trickle down to the commercial [health plans]. Competition could bring prices down.”

Access & Advocacy

Panelists agreed that lowering costs to patients was a surefire way to improve access to advanced medicine like biologics and biosimilars. And the value of those medicines could hardly be overlooked through the day’s discussions.  

From physician’s descriptions of their patients’ remarkable progress on biological therapies to Rolf Benirschke’s marvel at the transition from steroids to “unbelievable biologics” for Crohn’s and inflammatory bowel disease, the value of improving patients’ access to biologics and biosimilars loomed large.  Benirschke encouraged advocates and physicians in the room to continue their work, allowing advocacy to “fuel you like it fuels me.”

Social media activity from the day is available at #BiologicsSummit2019.

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2018 Summit on Balanced Pain Management

Before Justin Minyard was keynote speaker at this week’s fifth annual National Summit on Balanced Pain Management in Washington, DC, he was a respondent at the Pentagon on September 11.  A high-level interrogator serving the United States Army during tours in Afghanistan and Iraq.  And a prime example of why comprehensive, integrative pain management is critical.

A retired master sergeant, Minyard sustained multiple injuries during his deployments.  But only after six surgeries and a life-threatening addiction to prescription pain medication did Minyard find the balanced approach to pain that he needed.

With the help of a team of physicians and an implanted spinal device that electronically blocks pain signals, Minyard is back to being the father and husband he wants to be.  “I’m in control of my pain instead of the pain controlling me,” Minyard emphasized, “I’m empowered.”

His theme of empowerment ran throughout the day’s summit, which drew policymakers, academicians, health care providers, patients and nonprofit leaders.

Patient Engagement

Empowering the patient begins with listening.  So explained Anita Gupta, MD, of Heron Pharmaceuticals and Princeton University’s Keller Center for Innovation, who urged fellow physicians to “invest in the human relationship.”  “Take time to know the patient,” she insisted.

Panelist Roy Soto, MD, an anesthesiologist from Oakland University William Beaumont School of Medicine echoed those sentiments.  “We spend a lot of time talking about the medicine, the system, but we have to focus on the patient,” Dr. Soto noted.

Panelist Travis Bornstein agreed.  Bornstein and his wife founded Ohio-based nonprofit Hope United after losing their young son to opiate addiction.  The physician who initially prescribed opioids for their son’s sports injury didn’t properly explain the risks, Bornstein recalled.  After “sitting in shame” for five years, Bornstein now honors his son’s memory by sharing his story and supporting families with similar struggles.

Another voice that’s important to the conversation is that of women, as Erin South from the Food and Drug Administration Office of Women’s Health explained.  Women experience pain and withdrawal differently, and they are often told they’re “misstating” their pain, South explained.

Complementary Approaches

A better approach wouldn’t just incorporate patients’ voices.  It would serve their bests interests.  A panel discussion on comprehensive, integrative pain management outlined the importance of complementary approaches to pain, such as cognitive therapy and massage therapy. 

Taylor Crouch, PhD, a pain psychologist from the Medical University of South Carolina, described how cognitive treatment can be a pivotal part of pain management, as chronic pain can often overlap with depression and anxiety.  Crouch emphasized that these services must “be more accessible in terms of locations where patients can get treatment.”

Fellow panelist Niki Munk, PhD, of Indiana University pointed out that massage therapy can be beneficial for patients in pain but is often overlooked by insurers, who may view it as “a luxury, a pampering.”

And panelist David Morrisette, PT, PhD, of the Medical University of South Carolina spoke about the role that genetics could play in how some patients sense or respond to pain.  He also emphasized the importance of preventive measures that address pain before it becomes chronic. Goal setting and cognitive therapy can be effective, he noted.

Jason Bellamy of the American Physical Therapy Association moderated the panel, noting the role of diet and exercise as critical but tough to implement.  “It’s changing human behavior, and that is extremely difficult” Bellamy acknowledged.

Technology-Based Solutions

Beyond complementary approaches and behavioral changes, balanced pain management can also entail technology-based solutions.

Lynn Webster, MD, of PRA Health Sciences described the role of virtual reality in addressing pain.  While widely recognized as a source of entertainment such a video games, virtual reality can provide what Dr. Webster referred to as “distraction therapy,” offering short-term pain relief that may also have a lasting benefit.  Some versions of virtual reality allow patients to visualize pain relief, which can translate to physiological benefits.

Michael Leong, MD, of Stanford University and Dave Spinner, DO, of Mount Sinai Hospital discussed the value of neuromodulation in a panel discussion with Paul Christo, MD, of Johns Hopkins University School of Medicine.  Dr. Leong described spinal cord stimulation can disrupt dependence on opioids and can also provide meaningful pain relief for patients who want to be “awake” and “participate with family” rather than being overly medicated.

Dr. Spinner spoke on peripheral nerve stimulation, which has demonstrated significant pain relief for stroke victims.  Explaining how the stimulation works, Dr. Spinner said, “If we can find a way to stop a nerve from firing, we could stop the pain.”

But treatments like virtual reality, massage therapy and spinal cord stimulation can help only if patients can access them.

Coverage Challenges

In a panel discussion on coverage for balanced pain management, Dania Palanker of Georgetown University’s Center on Health Insurance Reforms explained that certain trends don’t bode well for balanced pain management.  Short-term health plans, for example, might exclude some complementary approaches.

Adam Seidner, MD, of insurance provider The Hartford suggested that many insurers were, however, trending toward “Center of Excellence” models, where reproducible results could prove that interdisciplinary programs are a good use of limited resources.

Dylan Landers-Nelson of National Business Group on Health noted that the opioid epidemic has sparked more interest by employers in how pain and addiction are treated by the health plans they offer their employees. But, “if you’re going to overcorrect by dramatically cutting down on opioid coverage, you have to have something to replace it with to treat patients’ pain,” Landers-Nelson emphasized.  He noted that employers should think “comprehensively” about pain, substance use disorder and mental health.

Stacey Worthy of DCBA Law & Policy explained why policies should consider unintended consequences to patients.  “Some states have gone too far,” Worthy argued, referencing laws on the duration or dose of opioids that could make it confusing for physicians treating patients in pain.  For “a subset of patients with chronic pain,” Worthy emphasized, controlled medications may be part of the balanced treatment plan.

Bob Twillman, PhD, of the Academy of Integrative Pain Management, moderated the discussion.

Regulatory Efforts

Federal regulators are doing their part to drive solutions as well.  Vanila M. Singh, MD, Chief Medical Officer at the Department of Health and Human Services, outlined the work of the Pain Management Best Practices Inter-Agency Task Force. While opioid-related deaths are down 1.4 million since 2015, addiction to heroin and the illicit use of fentanyl pose a growing problem for policymakers.

The Department of Health and Human Services continues to implement its five-point strategy for addressing the nation’s crisis.  It “cannot be done without a multidisciplinary approach,” Dr. Singh emphasized.  The approach also encourages education, access to care and acute pain guidelines for common surgical procedures


More than just public dialogue, the day’s proceedings are intended to fuel the call to action issued by Brian Kennedy, executive director of the Alliance for Patient Access, in his opening remarks.

“America’s opioid abuse epidemic has brought the question of pain management front and center in the national conscience.  Now, it’s on us.  Not to stand by and hope that the policies that emerge from this crisis represent the interests of men and women across the country.  But to lead – by defining and demanding policies that give patients access to balanced pain management.”

The National Summit on Balanced Pain Management was convened by the Institute for Patient Access and co-hosted by the Alliance for Balanced Pain Management and the Alliance for Patient Access.  See #BPMSummit2018 for photos and tweets from the day’s event.


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AfPA-IfPA Health Policy Leadership Retreat

What’s the value of a trusting relationship with a good doctor?  A life-altering medication? Choices among medical treatments? These and other topical questions took center stage at the Alliance for Patient Access and Institute for Patient Access’ first-ever health policy leadership retreat, held in San Diego.

Entitled, “Worth it?,” the two-day event combined expert panel discussions, case study analysis and brainstorming sessions to examine value and valuation in today’s health care system. The audience included physician members of the Alliance for Patient Access, as well as advocates, health economists and other stakeholders.

The Physician-Patient Relationship

The event didn’t shy from tough issues.  AfPA Chairman David Charles, MD, opened the program with a hard look at the physician-patient relationship.  Plagued by burnout, physicians face institutional pressure to squeeze in as many patients a day as possible. They also deal with electronic medical records, which can compel them to look at a screen rather than give their full attention to a patient during an appointment.  And then there’s health plans’ utilization management – requirements like prior authorization or fail first, which pile on paperwork and delay physician-prescribed care.

One physician, gesturing to a projected photo of a patient and physician, explained, “We’re doing less and less of that, and more and more of everything else.”   

But the group was firm: Despite added pressures, the physician-patient relationship remains a cornerstone of quality health care.   Some of its benefits are measurable. As Dr. Charles noted, a strong physician-patient relationship means patients are more likely to take medication as prescribed and more likely to make recommended lifestyle changes such as exercising or quitting smoking.  The relationship also correlates with lower ER rates and better mental health for patients.

There are also less tangible, but equally valuable benefits.  “Statistics don’t tell the whole story,” one physician insisted.  “How do you quantify the value of a 10-year relationship with a patient?  Of seeing them go from a whole pack down to two cigarettes a day? It’s baby steps,” he noted, adding “That’s hard.”

Dr. Charles charged the group with advocating for a health care system that protects and reveres the physician-patient relationship.

Value & Valuation

The event also took up questions of value and health technology assessment.  In a panel discussion entitled “Searching for Value,” The Pink Sheet’s Nielsen Hobbs spoke with Clara Soh of Avalere Health and Mark Linthicum of the Innovation and Value Initiative on the topic of valuation.  

The status quo is problematic, panelists agreed.  Soh called current valuation tools “blunt instruments,” noting that value is “very different depending upon who you are.”  

On the topic of the Institute for Clinical and Economic Review, Linthicum observed that ICER’s findings “defend coverage decisions rather than support access.”  Soh called it “economic malpractice” to conduct a valuation of a product before having all necessary information, which ICER frequently does.  

A better approach would incorporate diverse perspectives – data beyond just clinical trials.  That might include quality-of-life issues such as a condition’s burden on both the patient and the patient’s caregiver.  

Valuation should also function to inform patient and physicians’ decisions – but not to make their decisions for them.  After all, participants agreed, valuation is not a one-size-fits-all endeavor.

Drug Pricing & Patient Access

An afternoon panel explored drug pricing and patient access.  The Alliance for Patient Access’ Susan Hepworth moderated a panel discussion, arguing that the high price of drugs reflects a broken drug system. Panelists Wayne Winegarden of the Pacific Research Institute and Mike Ybarra, MD, of PhRMA agreed.  

Part of the problem is the convoluted nature of the rebate system.  “The price you hear about in the news isn’t actually the price that’s being paid,” Winegarden explained, noting, “’How much do drugs cost?’ We should be able to answer that question.  But we can’t.”

Pharmacy benefit managers, who push for higher rebates, can create problems of their own.  Dr. Ybarra alluded to rebates on insulin being as high as 70 percent of the drug’s price.  The problem? Some patients’ out-of-pocket expense is based on a drug’s list price. So even if aggressive rebate negotiation drives down the net price of a drug, that won’t make it less expensive for patients.  Co-pay assistance from manufacturers can help patients. But, as panelists noted, the increase in co-pay accumulator programs are making that complicated.

What is working?  Competition, argued Dr. Ybarra. He alluded to the FDA’s success in streamlining and quickening the pace of drug approvals.  He added, “Negotiation does happen in the health care system.”

Participants noted that, as with valuation, pricing decisions should include input from diverse stakeholders.  Patient access should be a key consideration, the group agreed, but all parties should be ready to share both the risks and the benefits of prescription medications.

Real-World Implications

As a follow up to both panel discussions, participants analyzed hypothetical case studies.  The situations sparked debate about how much financial responsibility patients should bear, how physicians should handle tough prior authorizations, and how physicians should advise patients who are in tough financial situations that affect their treatment.


Because, while the event explored issues from a policy lens, “These issues impact real people,” AfPA Executive Director Brian Kennedy reminded the group.  AfPA members plan to use principles that arose from the discussion to inform policy and advocacy work moving forward.


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2018 Infant Health Policy Summit


Advocates cannot reach every infant or every family, acknowledged National Coalition for Infant Health Medical Director Mitchell Goldstein, MD, as he welcomed attendees to the fourth annual infant health policy summit on Thursday.  But, he emphasized, “We can impact policy.”

The daylong event brought together health care providers, parents, advocates and congressional staff in Washington, DC, to consider how policy can address the challenges facing infants and their families. But as the day’s discussion made evident, those challenges can be staggering.

Congenital Heart Disease

Congenital heart disease, for instance, loomed large during the summit.  Katie Mooshian of Mended Little Hearts described her son Charlie’s experience with single-ventrical physiology, whereby only one of the heart’s two ventricles pumps blood as it should.

Of Charlie’s birth, Mooshian recalled, “I handed over a vulnerable, tiny infant to have his heart stopped, to be put on bypass, and hopefully to be given back to me.”  Katie’s son Charlie ultimately survived multiple surgeries.  Meeting the challenges of congenital heart disease, Mooshian emphasized, requires providing infants and their familes with “continued support, advocacy and intervention.”

Beyond those measures, another factor plays an important role in the lives of infants with congenital heart disease: nutrition.  In a panel discussion, Jodi Lemacks of Mended Little Hearts, described struggling to breastfeed her infant son Joshua, who was born with congenital heart disease.  “Feeding your child is the one way you know your child’s going to be nourished, that your child’s going to survive,” Lemacks explained.  Ultimately, Lemacks noted, breastmilk helped Joshua gain weight and boost his immunity.

Clinical research is underway to more closely examine the benefits of human milk for infants like Joshua.

David Rechtman, MD, of Prolacta Bioscience explained that human milk – whether breastmilk, donor milk or human milk-based fortifier – has been shown to help protect premature infants from deadly intestinal conditions.  Now researchers hope to confirm that human milk also provides benefits for infants born with congenital heart disease.   “If you give them more calories and more protein, they’re going to grow better,” Dr.  Rechtman noted.

Respiratory Syncytial Virus

Another struggle also generated vigorous discussion: Respiratory syncytial virus, or RSV.  Suzanne Staebler, DNP, of Emory University presented results from the National Coalition for Infant Health’s national survey on awareness of RSV.  The virus is the leading cause of hospitalization in children under one year of age.  The survey revealed that parents have high levels of concern about RSV but feel unprepared to protect their young children.  Specialty health care providers such as neonatologists and NICU nurses, meanwhile, reported seeing RSV cases regularly and proactively monitoring patients for the disease.

Blogger and former television news anchor Shanisty Ireland brought that research to life by describing her own family’s battle with the disease in a panel discussion on RSV.  Ireland recalled taking her son Adam to the hospital after he exhibited signs of distress, explaining, “I still didn’t know how close he was to dying.”

“I asked people, ‘Pray for him.  He has RSV,’” Ireland recalled, adding, “Not a single person had ever heard of it.”

Neonatologist Mitchell Goldstein, MD, acknowledged widespread misinformation about the potential severity of the disease.  Ireland recalled thinking of it as something akin to the common cold. “For some babies,” Dr. Goldstein explained, “it’s a whole lot more.”

The experience turned Ireland into an advocate. “RSV had a hold on my baby,” Ireland explained, “but now I feel like I have a hold on RSV.”

Support for Families

Ireland wasn’t the only event speaker who turned adversity into advocacy.

Keynote speakers Stephen Bowen, former NFL player, and his wife Tiffany Bowen, PhD, lost their premature infant son Skyler to intestinal infection just days after his birth at 24 weeks.  In the face of overwhelming grief, the couple persevered – “staying strong” for Skyler’s surviving twin brother and the couple’s older daughter.

Stephen’s strength under stress led him to receive the Ed Block Courage Award.  Tiffany earned her doctorate and came through post-traumatic stress disorder to create Skyler’s Gift Foundation along with her husband.  The nonprofit aids unprepared families in paying for the funerals of premature infants who don’t survive.  The organization also provides funding for those families’ grief counseling.

In recalling the loss of young Stephen, the couple reflected upon the worry and grief they felt – but also the dedication of their sons’ health care providers.  People who work in the NICU “are heroes,” Tiffany emphasized.

NICU Safety

Those heroes face challenges of their own.  Just consider the issue of hospital tubing.  Addressing the summit audience, Rebekah Thacker, MSN, of the University of Arkansas Medical Center described concerns about the use of tubing connectors known as ENFit in NICUs.  As described in a 2017 video from the National Coalition for Infant Health, liquid can “hide” in the reservoir at the tip of the connector – potentially dosing tiny infants with more medication than intended.

Thacker described her efforts to push back against industry’s drive for ENFit adoption.  “Nobody knows the neonatal population like a neonatal nurse,” Thacker insisted.

“Still a Preemie”

And that population is broader than one might expect.  The National Coalition for Infant Health released at the summit a new video emphasizing the full spectrum of prematurity.  “Still a Preemie,” explains that preemies don’t always conform to stereotype.  Late-preterm infants born from 34 through 36 weeks’ gestation, or those who are born premature but at a “normal” birthweight, can still struggle with feeding issues, jaundice, respiratory conditions and development delays.  And their parents can feel the effects too.

Just ask Kelli Kelly of the parents support organization Hand to Hold.  When Kelly’s daughter Lauren was born at 34 weeks, she “looked good, looked healthy” Kelly recalled in an address to summit attendees.  But the appearance was deceiving.  Lauren required NICU care, so Kelly left the hospital “with empty arms.”  She recalled waking during the nights to pump breastmilk for her daughter, whose developmental challenges made it impossible to breastfeed.  Kelly suffered emotionally.  “It’s hard to bond with a baby that’s in a glass box,” she recalled.

Meanwhile, medical bills rolled in.  Because of baby Lauren’s size, she didn’t qualify for Medicaid coverage.

Several organizations are working to improve conditions for families like Kelly’s.  The Association of Women’s Health, Obstetric and Neonatal Nurses has developed evidence-based clinical practice guidelines for late preterm infants.  Meanwhile, the National Perinatal Association has published a similar document that also reaches parents, social workers, therapists and lactation consultants, among others.

In a discussion moderated by Sue Ludwig of the National Association of Neonatal Therapists, the group explored the challenges of infants born late-preterm. “Every organ in the body is premature,” emphasized Raylene Philips, MD, of the National Perinatal Association.

Jean Salera-Vieira, MS, of the Association of Women’s Health, Obstetric and Neonatal Nurses, noted the importance of support for these infants’ parents.  Nurseries for infants born after 32 weeks’ gestation “don’t have same level of parent support that a NICU might,” she explained.

Congressional Action

Another opportunity for policy change lies with Congress’ PREEMIE Reauthorization Act of 2018.  Staff representing the bill’s authors, Senator Lamar Alexander (R-Tenn.) and Senator Michael Bennet (D-Colo.), explained that the bill would reauthorize pivotal Centers for Disease Control and Prevention research on preterm births. The bill also includes screening measures and services for pregnancy depression and substance abuse treatment.

Introduced earlier this year, the PREEMIE Reauthorization Act passed the full Senate over the summer.  Rep. Anna Eshoo (D-Calif.) and Rep. Leonard Lance (R-NJ) are working to advance the bill in the House of Representatives.

See photos and social media highlights from the day at the National Coalition for Infant Health’s Facebook page.


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