The Northern Virginia Health Policy Forum hosted a distinguished panel at its July event. The discussion, which included Lisa Murdock, chief advocacy officer, American Diabetes Association; Rob Goldsmith, director, advocacy and policy, Endocrine Society; and Kate Thomas, chief advocacy and external affairs officer, Association of Diabetes Care & Education Specialists, addressed how the Centers for Medicare & Medicaid Services is working to provide access to adequate, affordable healthcare for people with diabetes.
The conversation also reminded us that there are several pieces of legislation pending in Congress which have the potential to impact the lives and pocketbooks of Americans living with diabetes, as well as the bottom line of the federal budget.
Among these is the Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act, introduced in the June by Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME), co-chairs of the Senate Diabetes Caucus. Under the legislation, group and individual health insurance plans would be required to waive deductibles and to offer enrollees a cost sharing option of no more than $35 month for at least one insulin of each type and dosage form. The bill would also prohibit the use of utilization management tools including prior authorization requirements for insulin use.
The INSULIN Act is very similar to the Affordable Insulin Now Act which passed the House in March by a margin of 232-193, with 12 Republican votes. However, the INSULIN Act goes a step further, by directly addressing the manner in drug prices are negotiated. Under the INSULIN Act, insurance plans and pharmacy benefit managers would be prohibited from collecting rebates on insulin.
Despite Senate Majority Leader Charles E. Schumer (D-NY) having previously declared that that the INSULIN Act would come to the floor for a vote, it is clear that it won’t be considered this work session. And, as the Democrats’ Inflation Reduction Act (IRA) moves forward, there are murmurs that insulin pricing may yet be added to the final package, but no confirmation as this article goes to press.
The cost of insulin is a real problem with real life consequences. A 2019 report prepared by the Senate Finance Committee found that some manufacturers “increased their insulin prices more than 500 percent” between 2012 and 2016. One quarter of subjects in a study of patients at the Yale Diabetes Center reported underusing insulin because of cost concerns—a choice that puts them at risk for a frightening array of complications, including diabetic ketoacidosis, diabetic retinopathy, kidney failure, infection, and neuropathy.
Currently 22 states and the District of Columbia have insulin pricing caps or cost restrictions in place. In a video posted to Twitter on July 7, California Governor Gavin Newsom said that his state was “taking matters into our own hands” and would manufacture its own insulin. California’s current budget includes $100M for the project, $50M of which is earmarked for the development of low-cost insulin products, with the remainder going towards a California-based facility for the manufacture of insulin.
In expressing support for the Affordable Insulin Now Act, the American Diabetes Association described the legislation as “especially important right now, given the outsized impact of the COVID-19 pandemic on the diabetes community.” The organization went on to say, “It’s time to pass a national co-pay cap to bring economic relief to millions of Americans forced to stretch beyond their means every month to pay for their insulin.”
Diabetes advocacy groups have long pointed to rebates as driving up the cost of insulin. The Pharmaceutical Care Management Association, which represents pharmacy benefit managers, has pushed back, blaming insulin prices on “arbitrarily high prices” on the part of drug manufacturers. In its criticism of the INSULIN Act, the group pointed to a report from the Congressional Budget Office, which estimates that the legislation would add approximately $23B to the federal budget over 10 years.
Diabetes legislation is not confined to insulin pricing. The Expanding Access to Diabetes Self-Management Training (DSMT) Act, which was introduced last November, would expand Medicare’s coverage of outpatient self-management training programs for diabetics. It would also require the Center for Medicare and Medicaid Innovation to pursue a virtual training model and address current payment and referral policies. Remarkably, under current Medicare rules providers in a hospital emergency department—an especially likely point of contact for diabetics—can’t refer patients to self-management programs.
We are also watching for any movement on the Amputation Reduction and Compassion (ARC) Act, which was introduced by Rep. Donald Payne, Jr (D-NJ) and would establish coverage of peripheral artery disease (PAD) screening tests for at-risk Medicare and Medicaid beneficiaries with no cost-sharing requirements. As you’ll read in April Gutman’s article on disparities in the management of diabetic foot ulcers, PAD screenings can be an important step in reducing lower extremity amputations.