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Topic: Part D
I have been known to utter “holy cow” in my day, and the recent Centers for Medicare & Medicaid Services (CMS) Health Plan Management System (HPMS) memo allowing step therapy for Part B drugs was the reason for my most recent exclamation. Who saw this coming?
The Department of Health and Human Services (HHS) issued its blueprint for dealing with the high price of prescription drugs in May, and the administration is finally undertaking a number of initiatives to operationalize the proposals. So far, as seen from the updates below, the proposals will have the biggest impact on pharmacy benefit managers (PBMs) and payers.
What is the definition of medication reconciliation?
The Joint Commission defines medication reconciliation as the process of comparing a patient’s medication orders to all of the medications the patient has been taking in order to identify and resolve medication discrepancies.1
Surprise, the House actually passed a bipartisan healthcare bill on June 22 that had support from almost all members of both parties. H.R. 6, Support for Patients and Communities Act, is a comprehensive opioid bill that combines more than 58 individual bills intended to address the national opioid epidemic. The bipartisan bill passed 396-14 with only one Democrat voting against it. The impetus was political pressure in an election year to address a problem that results in the death of 115 Americans each day. A recent CBS poll showed 71 percent of all Americans and 78 percent of Republicans support a government response to the crisis.
Biosimilars have finally been accepted by the popular crowd. Coverage year 2019 (CY2019) is going to see some changes for how biosimilars are being reimbursed. In 2015, the first biosimilar product, Zarxio (filgrastim), was approved in the U.S. An approved biosimilar is a medication that has been shown to be highly similar to a Food and Drug Administration (FDA)-approved biologic, the reference product. Only minor differences in clinically inactive components between the biosimilar and reference product are allowed, and there must be no meaningful clinical differences. However, a biosimilar is not considered a generic drug, which is approved through a different pathway. Due to the inherent complexities of biologics, it is not possible to make an identical copy of a biologic. Traditional, small-molecule drugs are made through a predictable set of chemical reactions, but biologics are made using manufacturing processes (e.g., cell production, purification processes) and living organisms (e.g., cell lines) that are unique to each manufacturer. Although not a generic from a molecular or manufacturing perspective, biosimilars do function as a generic in intent. Meaning, biosimilars help increase access to biologic medications and potentially lower healthcare costs through competition. There have been several company announcements touting the cost savings potential of biosimilars. A recent example is Mylan’s approval of it’s biosimilar Fulphila, which has promised that it will come to market with “double-digits reduction” in price compared to the reference product Neulasta.
Health and Human Services (HHS) Secretary Alex Azar was in front of the US Senate Health Committee for a hearing today on drug pricing. His prepared remarks freaked out the market open saying the US “fundamentally may need to move toward a system without drug rebates, where PBMs and drug companies just negotiate fixed-price contracts.”
A bipartisan group of U.S. senators introduced legislation on Wednesday, March 14, that would prohibit pharmacy benefit managers (PBMs) from imposing “gag clauses” in pharmacy contracts that bar pharmacists from telling patients when the out-of-pocket cost of drugs is less than the copayment through their insurance. If pharmacists violate the gag clauses, PBMs may end the contracts or otherwise impose penalties—a practice widely criticized for inhibiting price transparency and contributing to rising healthcare costs for patients.