10/02/2018

ASK MSHO

October 2018, Frequently Asked Questions

Question: Is it true that Medicare Advantage plans will be able to implement “step-edits” on Part B drugs that we administer in our clinics beginning in 2019?

Answer: Yes, On August 7, 2018, CMS rescinded the September 17, 2012, HPMS memo “Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services,” and issued new guidance that recognizes Medicare Advantage (MA) plans may use step therapy for Part B drugs, beginning January 1, 2019, as part of a patient-centered care coordination program. CLICK HERE to read the announcement
 
https://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/Downloads/MA_Step_Therapy_HPMS_Memo_8_7_2018.pdf

Question:  How could MA plans be allowed to implement step therapy when they are required to follow traditional CMS coverage policies?

Answer:  CMS explained that its new guidance is based on Section 1852 of the Social Security Act, which allows MAOs to implement utilization management tools. In its 2012 guidance, the agency stated that it interpreted its regulations under 42 CFR 422.101 to prohibit step therapy for Part B drugs unless such step therapy was specifically permitted under a national coverage determination (NCD) or a local coverage determination (LCD). In the recently released guidance, based on the agency’s statutory interpretation, CMS now advises MAOs that step therapy is permitted for Part B drugs where the NCD or LCD is silent on the use of step therapy. 

Question: How does CMS interpret the requirement that step therapy only be applied to new prescriptions or administrations of Part B drugs for enrollees that are not actively receiving the affected medication? 

Answer: Medicare Advantage Organizations may only apply step therapy policies to new prescriptions or new administrations of Part B drugs. This means that enrollees currently receiving a particular drug under Part B cannot be required under a step therapy policy to change their medication. For example, a new plan enrollee currently undergoing a particular drug therapy cannot be forced to switch to the preferred drug therapy of the plan upon enrollment. Similarly, an existing enrollee already undergoing a particular drug therapy must not be required to change therapies should a plan establish or update a step therapy program. Consistent with Part D rules, CMS expects plans will follow a look- back period of at least 108 days to determine whether the enrollee is eligible for a new start prescription.

Question: Has CMS provided additional guidance on the language that should be included in the Annual Notice of Change (ANOC) and Evidence of Coverage (EOC) documents and explicitly state where the language should be inserted?

Answer: Yes, in their FAQ CMS stated; "MA plans must, at a minimum, disclose that Part B drugs may be subject to step therapy requirements in the plan’s ANOC and EOC documents. The ANOC and EOC can list each Part B drug that will be subject to step therapy or it can be more general.

In the ANOC, this information must be included under the Changes to Benefits and Costs for Medical Services. In the EOC, this information must be included in the Medical Benefits Chart under “Medicare Part B prescription drugs.” If these documents are already in production, plans may send out an addendum to the ANOC and EOC to appropriately inform enrollees of the change. ANOCs are due by 9/30 and EOCs are due by 10/15, so those deadlines remain for the addendum.

Note that Plan Finder links to plan websites, on which the ANOC and EOC documents that address utilization management procedures, such as step therapy can be found."

Question: Can MA plans require an off-label use of one Part B drug before a different Part B drug?

Answer: Consistent with existing Part D guidelines, MAOs will be permitted to require an enrollee to try and fail drugs supported only by an off-label indication (an indication only supported in the statutory compendia) before providing access to a drug supported by an FDA approved indication (on-label indication) if the off-label indication is supported by widely used treatment guidelines or clinical literature that CMS considers to represent best practices. Generally, CMS requires such authoritative guidelines to be endorsed or recognized by United States government entities or medical specialty organizations. We remind MAOs of the definition of a medically-accepted indication outlined in Chapter 6 of the Medicare Prescription Drug Benefit Manual, section 10.6.

Question: Can CMS clarify exception request requirements? What are the applicable adjudication timeframes?  

Answer: The timeframes set forth at 42 CFR §§ 422.568 and 422.572 apply to a request for a Part B drug. A request for a Part B drug is an organization determination request under Part C; therefore, the standard (14 calendar days) and expedited (72 hours) timeframes for Part C organization determinations apply to a request for a Part B drug.

Question:  Is it true that some of the savings from implementing this step therapy program must go back to the patient?

Answer:  Yes, Advantage plans must offer beneficiaries rewards in exchange for participation in these programs; such rewards can be gift cards or other items of value, but cannot be cash or monetary rebates.  For a good article on this topic CLICK HERE.