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With a new presidential administration taking over the helm in the United States, the road ahead for American healthcare and policies impacting diabetes stands at a crossroads.

The ongoing COVID-19 crisis and current reckoning on systemic racial disparities are changing priorities.

Yet longstanding diabetes policy issues remain top of mind: insulin affordability, overall drug pricing, access to supplies, and of course health insurance reform for more expansive and accessible care.

So what exactly will the priorities be in 2021 and beyond, for Congress, state legislatures, and patient advocates?

We at DiabetesMine have explored the outlook for the year ahead, by talking with key policy leaders, groups, and grassroots advocates.

George Huntley

“The pandemic has put healthcare on everyone’s radar in ways it wasn’t always as visible before,” says George Huntley, leader of the Diabetes Patient Advocacy Coalition (DPAC) and the newly rebranded Diabetes Leadership Council (DLC), who also lives with type 1 diabetes (T1D) himself. Both organizations advocate for positive legislation and policies on behalf of people with diabetes (PWDs).

No doubt the COVID-19 crisis has exposed many of our healthcare system’s glaring gaps and failures.

In fact, a December 2020 survey by the American Diabetes Association (ADA) shows just how brutal the pandemic has been on PWDs:

  • 43% of U.S.-based PWDs say they have delayed seeking routine medical care during the pandemic, often because they fear exposure to COVID-19.
  • 1 in 5 people say they have foregone or put off getting the technology they need to manage their diabetes, like an insulin pump or continuous glucose monitor (CGM). Most often, this is due to financial constraints.
  • Of those who use a CGM or insulin pump, 15% report they have delayed refilling needed supplies during the pandemic. 70% of those say that’s due to financial constraints or hardship.
  • 12% of PWDs have seen their health insurance disrupted since the start of the pandemic, often because they have lost their job or because the person on whose insurance they depend has lost their job.
  • Of those who say they are newly without health insurance, 19% were forced to go on Medicaid and 13% have become completely uninsured.
  • More than 1 in 4 people with diabetes reported the pandemic has disrupted their ability to get healthy food, compared to the 10.5% of the general U.S. population that experienced food insecurity in 2019.

“For months we have known that people with diabetes are at heightened risk during COVID. Yet what this data show is that the level of adversity facing our community from this crisis is at an even more critical point,” said the ADA’s CEO Tracey Brown. “As many as 40 percent of the COVID fatalities — 120,000 Americans — have been people with diabetes, and more in our community may be at risk of the worst of the virus’ effects because so many are now unable to manage their diabetes effectively.”

At the start of 2021, a group of 19 diabetes organizations formed a collaborative to urge the Centers for Disease Control and Prevention (CDC) to prioritize T1D at the same urgent level as type 2 diabetes, in terms of vaccine distribution. That’s an evolving issue that the Diabetes Community is razer-focused on as vaccines are being rolled out.

Fortunately, there were several positive changes in healthcare and diabetes care that happened as a result of the COVID-19 crisis:

  • an explosion in telehealth for many types of office visits
  • greatly increased use of CGMs in hospitals
  • relaxing of rules allowing for 90-day prescription refills, as well as limits on prior authorization requirements for more expensive medicines and supplies
  • Medicare and private insurance rule changes allowing PWDs to obtain new diabetes devices without an in-person visit to a physician

Some policy work for 2021 will involve advocating that those changes become permanent, if they’re not already.

Telehealth, in particular, is a boon to many PWDs because it helps them access efficient care from anywhere.

Advocating for telehealth to continue and grow comes down to convincing Medicare (and thus private insurers) to continue adequate reimbursement for physicians to provide virtual visits. Clearly, doctors need to be paid fairly for this type of work.

“If we go backwards on telehealth, it’s not a positive,” Huntley said. “The number one reason a Medicare recipient didn’t get to an appointment for needed care, prior to the pandemic, was lack of transportation. We all understand it has to be in the context of overall patient care, but for PWDs it could replace a few visits and help so many people. Let’s not hit the off switch, let’s keep it turned on and toggle the settings from there.”

National diabetes organizations like the ADA and JDRF have spent a lot of time in recent years hitting on healthcare reform issues and pushing to protect the Patient Protection and Affordable Care Act (ACA) that first passed in 2010, but has been under attack for the past decade largely by the GOP.

Not surprisingly, ACA-related research shows that having health insurance coverage makes a big difference in diabetes outcomes.

This will be a pressing topic during the next 4 years given President Joe Biden’s leadership and the Democrats’ control of both the U.S. House and Senate. It will be especially high priority before the midterm Congressional elections in November 2022, when passing legislation often gets more difficult, if not impossible.

“We’ve been playing defense for the past several years,” Huntley said. “But now is the time, with an administration and leadership change. No matter where your politics lie, having new leadership — especially Democratic leadership that’s more open — is a call to action. Advocates can have a positive influence.”

In November 2020, the DLC led a coalition of 12 diabetes orgs that released a consensus statement on health reform for PWDs, delving into various issues that will be a priority in the coming years. The key principles listed are:

  • Everyone deserves access to affordable and effective healthcare.
  • Diabetes care is preventive care. Long-term healthcare costs for people with diabetes are lower when they have the medications, devices, and services they need to manage their disease.
  • National healthcare reform must address the roles and incentives of major stakeholders in the healthcare coverage, delivery, and reimbursement systems, and realign their practices and obligations in support of patients’ rights to understand the terms of their coverage, compare treatment costs, and make informed decisions in collaboration with their healthcare providers; and affordably access individualized treatment needed to effectively manage chronic and acute health conditions.

The third point about transparency in coverage and pricing is definitely a hot-button issue.

The new Public Health Service Act, aimed at making hospital pricing for common services more transparent and more accessible for patients, officially went into effect Jan. 1, 2021. This means hospitals across the country are now required to publish and annually update their standard charges for 300 “shoppable services” in a reader-friendly file.

With 2021 marking the 100th anniversary of the discovery of insulin, there will likely be huge efforts to move the needle on affordability and access this year. Especially in the United States, where an insulin affordability crisis is more pronounced than anywhere else in the world.

Federal efforts to halt middlemen

A 2-year investigation into insulin pricing known as the Senate Finance Committee Report on Insulin Pricing was released on Jan. 13, 2021. The DLC applauded that report for shedding light on the incentives and rebate system that play into Pharma price-gouging for insulin.

“The report clearly shows that pharmaceutical companies are afraid to lower their list prices for fear that their pharmacy benefit manager (PBM) — “middleman” — will object to losing a piece of the transaction,” the DLC said in a statement.

“These middlemen have no incentive to lower prices, and we all have seen the effects of it in skyrocketing drug prices. We must dismantle the rebate system and other incentives that provide a conflict of interest to the party negotiating these prices.”

Most likely, the lawmakers who led the Finance Committee research — Sen. Ron Wyden (D-OR) and Chuck Grassley (R-IA) — will introduce legislation on the issue of insulin pricing before long, based on this Senate report. This effort follows hearings held in various Congressional committees through the years, since early 2017.

JDRF, ADA, and other larger diabetes organizations will continue to push on this issue. Already in early January 2021, the national Endocrine Society has published a list of specific policy changes it recommends to increase access to affordable insulin, including allowing government negotiation of drug prices, and elimination of rebates, along with a dozen other points.

“People with diabetes without full insurance are often paying increasing out-of-pocket costs for insulin resulting in many rationing their medication or skipping lifesaving doses altogether,” said Dr. Carol Wysham, the Society’s president-elect and a practicing physician at Rockwood/MultiCare Health Systems in Spokane, Washington.

The influential California-based nonprofit Beyond Type 1 (BT1) also tells DiabetesMine that it plans to focus on insulin pricing advocacy this year.

“On a U.S. federal level, our efforts in 2021 will be on both legislative and regulatory opportunities to curb prescription drug pricing, supporting efforts to re-introduce the Insulin Price Reduction Act (with modifications to reflect changes and additions in the current market),” reports Christel Marchand Aprigliano, chief advocacy officer for BT1 who lives with T1D herself.

The Insulin Price Reduction Act is a bipartisan bill introduced on October 29, 2019. In a previous session of Congress, it did not receive a vote.

States passing copay caps

On a state level, the ADA, BT1, and others continue pushing for insulin copay caps, already adopted by 14 states and Washington D.C., with some taking effect in 2021 or beyond.

“We expect a robust effort to bring financial relief through insulin-capping and rebate pass through bills and will be actively engaging through direct and grassroots lobbying,” Aprigliano said.

While critics point out that these state copay caps only impact a smaller number of PWDs because they’re focused on state-run plans only (rather than federally governed employer plans), these caps help a number of PWDs in need save money on insulin.

Grassroots #insulin4all advocacy

The ever-growing #insulin4all group of grassroots advocates is sending a strong signal that 2021 will be a landmark year for them.

In early January, they launched a new online effort called The Insulin Initiative, which appears to be focused on rallying behind local and state advocacy campaigns. One major priority is lobbying for a federal insulin price cap.

This effort is led by some of the more vocal advocates involved with #insulin4all, who also adamantly oppose the larger diabetes orgs that take pharmaceutical money.

The group will also undoubtedly be continuing its efforts organizing demonstrations in front of the headquarters of Big Three insulin manufacturers Eli Lilly, Novo Nordisk, and Sanofi.

The UK-based T1International organization has also recently signed a letter to the new Biden administration, urging several points that could impact drug and insulin pricing in the United States — including the launch of an investigation by the Federal Trade Commission (FTC) on the Big Three, for what’s described as anti-competitive “cartel-like” behavior in setting high prices.

Clearly, more wide-ranging change is necessary to ensure that insulin, meds and reasonable care are accessible and affordable for all. The DLC’s Huntley, for one, is putting his money on more bipartisan and collaborative efforts even among patient groups in the post-Trump era.

“Our voices together are more powerful. We must muster cooperation in raising the voice of 30 million-plus people who live with this disease,” he said. “That can get us our day in court, our day in committee rooms, to get these important issues addressed and passed across the United States.”