Medicare Part B Drugs Step Therapy Program for Jan. 1, 2022

Effective for dates of service beginning Jan. 1, 2022, Harvard Pilgrim is instituting a step therapy program for a number of Medicare Part B Drugs for members of our StrideSM (HMO) Medicare Advantage plans.

In keeping with a final rule (CMS-4180-F) issued by the Centers for Medicare and Medicaid Services (CMS) in 2019, the program will require Harvard Pilgrim members to have first tried certain preferred drugs to treat their medical condition before we will cover another non-preferred drug for that condition.

The step therapy requirement will only apply to new starts of Part B drugs — if a member has a paid claim for the non-preferred drug or there is clinical documentation of the member utilizing the non-preferred drug within the past 365 days, they will not be required to try the preferred drug.

Harvard Pilgrim has developed a Step Therapy (Part B Drugs) Medical Policy, which identifies the drugs for which the step therapy requirement applies, as well as their preferred alternatives:

Drug Class Non-preferred Product(s) Preferred Product(s)
  • Avsola
  • Renflexis
  • Inflectra
  • Remicade
Bendamustine HCI Injection
  • Treanda
  • Bendeka
  • Belrapzo
Bevacizumab – oncology
  • Avastin
  • Mvasi
  • Zirabev
Iron Preparation, Parenteral
  • Feraheme
  • Ferrlecit
  • Injectafer
  • Infed
  • Monoferric
  • Venofer
Leucovorin / LEVOleucovorin Injection
  • Fusilev
  • Khapzory
  • leucovorin injection
Neutropenia Colony Stimulating Agents – long acting
  • Nyvepria
  • Udenyca
  • Ziextenzo
  • Fulphila
  • Neulasta
Neutropenia Colony Stimulating Agents – short acting
  • Granix
  • Leukine
  • Neupogen
  • Nivestym
  • Zarxio
Paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome
  • Soliris
  • Ultomiris
Retinal Disorders
  • Beovu
  • Eylea
  • Lucentis
  • Macugen
  • Visudyne
  • Avastin
  • Mvasi
  • Zirabev
  • Rituxan
  • Rituxan Hycela
  • Riabni
  • Ruxience
  • Truxima
  • Herceptin
  • Herceptin Hylecta
  • Herzuma
  • Kanjinti
  • Ogivri
  • Ontruzant
  • Trazimera
Triamcinolone Acetonide Injection
  • Zilretta
  • triamcinolone acetonide injection
  • Durolane
  • Gel-One
  • Gel-Syn
  • Genvisc 850
  • Hyalgan
  • Hymovis
  • Monovisc
  • Orthovisc
  • Supartz
  • Synojoynt
  • Synvisc
  • Synvisc One
  • Triluron
  • Trivisc
  • Visco-3
  • Euflexxa

The new policy also outlines the criteria that must be met in order for a member to be approved for coverage of one of the identified non-preferred drugs, which includes documentation of one of the following:

  • History of use of at least one preferred product resulting in a substandard response to therapy
  • History of intolerance or adverse event to at least one preferred product
  • Rationale that the preferred product is not clinically appropriate
  • Continuation of prior therapy with the requested product within the past 365 days

Please refer to the Step Therapy (Part B Drugs) Medical Policy for complete information.

Publication Information

Annmarie Dadoly,

Joseph O’Riordan,

Kristin Edmonston,
Production Coordinator