Home Infusion Services for Part B Drugs in the Spotlight Amid COVID-19 Regulatory Changes

Coronavirus disease 2019 (COVID-2019) is altering healthcare not just for those suffering through the novel virus, but also for patients with other conditions, such as cancer or rare diseases, or for providers, who are stretched beyond their limits.

For the duration of the emergency, CMS is allowing numerous workforce changes to increase the capabilities and ranks of frontline healthcare workers. And late Thursday, CMS announced another change, allowing doctors to work across state lines and nurse practitioners to perform medical exams in nursing homes.

Many providers are pleased with the new flexibilities provided by CMS to ease up on regulations, such as on telehealth, during the national pandemic emergency.

Among the included changes CMS announced last month are temporarily relaxed provisions for home infusion therapy services related to billing, contracts with physicians, remote monitoring, and coverage determinations

On Thursday, the Community Oncology Alliance (COA) said it is worried that the safety of patients with cancer could be at risk with some of the changes. According to a statement drafted by its board, COA said it opposes the home infusion of chemotherapy, cancer immunotherapy, and supportive drugs related to cancer.

In addition, COA said home infusion “by a provider who may not be a trained oncology nurse and may not recognize or be prepared to treat any of the serious adverse reactions that frequently occur is of significant concern. Many of the side effects caused by cancer treatment can have a rapid, unpredictable onset that places patients in incredible jeopardy and can even be life-threatening."The infusion of other Medicare Part B drugs at home for noncancer diseases and conditions “may be reasonable,” said COA.

Providers at community oncology clinics are working to keep their high-risk patients as safe as possible by using the tools CMS has already provided, said COA, which represents independent oncology clinics.

Besides patients with cancer, others at risk from complications wrought by the virus are those with immunological conditions, asthma, and diabetes.

Not surprisingly, the National Home Infusion Association (NHIA) said recently the CMS telehealth changes in regards to infusion do not go far enough.

“While we are encouraged that CMS is acknowledging the need for broader access to infused drugs that are currently delivered across various settings, NHIA fails to see how relaxing physician supervision through the use of telecommunications technology, or broadening clinical indications for the limited number of Part B [Durable Medical Equipment, Prosthetics, Orthotics, and Supplies] DMEPOS drugs, will generate significant access to home infusion for seniors who need to avoid being exposed to coronavirus,” the organization said in a statement, calling for a bundled payment for professional services, supplies, and equipment paid to home infusion providers for each day of infusion.

Separately, a bipartisan bill was introduced last month in the House of Representatives that aims to give Medicare patients access to Part B home infusion drugs through payment reform.

Besides NHIA, the bill, the Preserving Patient Access to Home Infusion Act, is supported by purchasing organization Premier.