"Your voice of the transplant community"

Update on Protected Class Drug status from Partnership on Plan D

TRIO remains an active member of the Partnership for Plan D with on-going participation by the TRIO Public Policy committee. As you can see from the notes below of a recent meeting, this issue remains a concern for the transplant community . . .

Part D Partnership Meeting
June 11, 2014

On Wednesday, June 11 the Partnership for Part D Access held its monthly meeting/conference call.  There was good attendance from the member organizations.  Andy Rosenberg led the call for Thorn Run Partners (TRP). 

Mr. Rosenberg provided the group with an update on the Administration’s position related to the Medicare six protected classes policy.  He first explained that TRP was informed by congressional staff that during meetings with Senators, then Secretary-nominee for the Department of Health and Human Services (HHS), Cynthia Burwell, made statements indicating that the Centers for Medicare and Medicaid Services (CMS) intends to revisit the issue of six protected classes.  However, she committed to using regular process – notice and comment.  Additionally, seven Senators from the Senate Finance Committee (Senators Grassley, Crapo, Roberts, Burr, Isakson, Thune and Portman) submitted Questions for the Record (QFR) that requested information about the Department’s intentions toward the six protected classes policy.  All of the responses indicated the Administration’s intention to make changes to the policy, and reiterated their commitment to use regular order.  Mr. Rosenberg also highlighted for the Partnership members information contained in CMS’ final Medicare Advantage/Part D rule that indicates they are likely to pursue changes to the Medicare six protected classes policy.  He explained that in its final regulation, the agency states that the current statue related to six protected classes is “obsolete in light of the Affordable Care Act” and so it is “making a technical change to specify that until such time as we undertake rulemaking to establish criteria to identify, as appropriate, categories and classes of drugs for which we determine are of clinical concern, the categories and classes of clinical concern shall be as specified” in the statute presently. 

Mr. Rosenberg then provided the Partnership members with an update on the work happening with Senator Grassley’s staff to develop a legislative proposal.  Rodney Whitlock, Senator Grassley’s staff, said that the Senator will lead the legislative effort.  He also agreed that Senator Rockefeller should be given first right of refusal on being the lead Democrat.  Mr. Rosenberg noted that the legislative “fix” will focus on the underlying legislative language and not the regulation.  Optimally, the goal (from the Partnership’s perspective) would be to simply clean up and restate the 08 language or amend the ACA language to make it clear the agency only has authority to add new classes, not remove any of the existing six.  The authority to change the existing six would fall on Congress.  However, Mr. Whitlock said he wanted to look into concepts that might maintain agency authority to make changes, but require Congress’ approval.  TRP will continue to work with Mr. Whitlock and share updates as they are available.  TRP also has done initial outreach to key House committee staff to share the concept of amending the statute versus addressing the regulation.  Staff agreed that tactic seemed reasonable.

TRP also is proposing that in coordination with the release of a bill, the Partnership will hold a press event that would include the bill sponsors and key stakeholders and congressional briefings.   Mr. Rosenberg stated that the Partnership’s Communications Working Group will become more active and engaged in the planning of the press event.  If groups have key spokespeople to recommend, please contact Mr. Rosenberg.  In addition to the press event, TRP would like to propose organizing two briefings (one House and one Senate) – perhaps a week or two following bill introduction – to use it as an educational tool and also to identify possible co-sponsors.


Partnership members indicated their agreement with the proposed bill focus, press event and congressional briefings.


Mr. Rosenberg also informed the Partnership that for now, the proposed forums will be placed on hold.  The short term goal should remain focused on the bill introduction and gathering co-sponsors.  Mr. Rosenberg did note that there may be more opportunity for an event or events like this is 2015.

In closing, Mr. Rosenberg asked everyone to mark their calendars for the next Partnership meeting/conference call on July 9 at 11am.