The Access to Prescription Digital Therapeutics Act, introduced in March, has the backing of the Academy of Managed Care Pharmacy.
The burgeoning digital therapeutics industry is pushing for passage of federal legislation that would create a separate benefit category for their product and pave the way for Medicare and Medicaid coverage.
The Academy of Managed Care Pharmacy (AMCP) is also backing the legislation, which is called the Access to Prescription Digital Therapeutics Act.
In a prepared statement, AMCP CEO Susan Cantrell, M.H.L, RPh, CAE, said the law will ensure that the new innovative therapies are available to Medicare and Medicaid beneficiaries. “Prescription digital therapeutics are effective in treating some of the most devastating diseases affecting patients, including substance use disorder and Parkinson’s disease,” Cantrell said.
The legislation, introduced in early March, is sponsored by Sen. Shelley Moore Capito (R-West Virginia) in the Senate and Rep Mike Thompson (D-California) in the House.
The bill defines prescription digital therapeutics as therapies that primarily use software to achieve their intended result; that have a cleared or approved indication for prevention, management or treatment of a medical disease, condition or disorder; and have been cleared or approved under sections 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act.
The bill, which was introduced in early March, also requires the establishment of a payment methodology and product-specific HCPCS codes.
“Our understanding, my understanding, is that Medicare fee for service, when they look the definition of a drug and a definition of service, they are unclear whether or not PDTs (prescription digital therapeutics) fall in the statute. And when they are unclear they need Congress to clarify, so hence the bill,” Yuri Maricich, M.D., chief medical officer of Pear Therapeutics, one of the leading digital therapeutics makers, said during an interview at the AMCP annual meeting last week in Chicago.
The legislation would “facilitate” the mandating of Medicare coverage, Maricich said, provide some clarity for state Medicaid programs weighing coverage by establishing a benefit category for prescription digital therapeutics.