Congress must act now: The 21st Century Cures Act’s  negative impact on vulnerable patients
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A year-and-a-half ago, doctors told John Ryals to put his affairs in order because his heart was failing. He took them at their word, writing a check for his funeral and confirming his memorial service plans. But thanks to home infusion of inotropic medication, that’s not how the story ended for this former member of the Florida House of Representatives.

Today, at 83, he works 25 to 30 hours a week as a real estate agent and still lives in the home he’s owned for 40 years. Home infusion therapy for end-stage heart failure makes that possible for Ryals. “It’s changed my life. Without it, I would be dead,” he says.


But an unintended consequence of the 21st Century Cures Act, which went into effect Jan. 1, is taking away that possibility for many Medicare patients in John’s situation.

Ryals is one of 5.7 million heart failure patients in the United States. Inotropic medication helps him and others with advanced heart failure breathe easier and be more active. It keeps some patients alive while they await a heart transplant; for others, it improves life quality for them and their loved ones during the difficult end stages. Patients need to receive the therapy 24/7, which makes home infusion ideal.

Patients almost always prefer to remain home, where they are comfortable and can continue to enjoy their families and activities, as well as avoid exposure to virulent infections. Home infusion also is less costly than care provided in a hospital or nursing home. Yet under the Cures Act, some patients, who are already facing difficult healthcare conditions, may be forced to seek care in a hospital or nursing home. Ryals says he can’t imagine how different his life would be if he couldn’t live at home. Read Ryals' story as well as those of other patients who recount how home infusion makes their lives richer.

The legislative oversight was inadvertent. The Cures Act changes the payment structure for infusion drugs under the Part B Durable Medical Equipment (DME) benefit. Previously, the Medicare reimbursement rate was based on Average Wholesale Price (AWP), which covered service-intensive clinical therapies to administer drugs for heart failure and immunotherapy infusions. However, Section 5004(a) of the Cures Act reduces the drug reimbursement structure, and there is no separate reimbursement for the services required to deliver these infusion services. While Section 5012 includes a separate service payment, it doesn’t become effective until 2021.

That means a gap of four long years without home infusion coverage for many Medicare patients. To rectify this, a coalition of patients, families, caregivers, providers and other advocacy partners is urging the U.S. Congress to immediately fix this oversight. Without a legislative solution, patients who currently rely on home infusion care may lose that access, placing even greater demands on them, their caregivers and family members.

The 21st Century Cures Act promises to help millions of Americans via a variety of wide-ranging initiatives. But with regard to its provisions in the field of home infusion, the reality is that many others may lose access to care, costing the Centers for Medicare and Medicaid (CMS) money. This needs to change.

Having served as speaker pro tem during his 14-year tenure in the Florida state legislature, John, who retired from politics in 1980, understands the legislative process. The Cures Act needs to be amended ASAP, he notes. “Who in the world would want to live in a nursing home if they didn’t have to?” he says. “I like being a productive member of society and home infusion has changed my life in every way possible.”

Paul Mastrapa is CEO of Option Care, a provider of home infusion therapy services.

The views expressed by this author are their own and are not the views of The Hill.