December 2020

National Public Policy Report

Your Public Policy Committee is committed to the broadest possible sharing of information about legislative and policy activities that can benefit the entire transplant community. One of the ways we plan to advance that commitment is by sharing information about positive activities in local areas with the larger community. We are thus asking that you please share with us any information you might have about specific legislation that is already in place in your State or under consideration in the state legislative process so that we can share these potential best practices as widely as possible. Please do not hesitate to contact Rodger Goodacre at rodger.goodacre@gmail.com, Ira Copperman at irajay2004@gmail.com or Lorrinda Davis at ldavis@trio-oklahoma.org. Thank you in advance and we look forward to talking and working with you.

THE PARTNERSHIP FOR PART D ACCESS

The regular monthly meeting of the PARTNERSHIP activities group met recently to keep its members informed on the latest legislative and departmental activities affecting open access to prescription drugs under the protected class policies on Medicare. Changing the policy could cause serious disruption in the ongoing mental and physical health of protected class patients. Catherine Finley from Thorn Run Partners, the long-time guiding member of the Partnership, updated the group on several points: The political and election activities for most of this year have kept the limelight from seeing any substantive changes or recommendations to alter current policies that affect the protected classes; The Partnership is committed to establishing contact with the new Executive leadership team as soon as possible in 2021; The Partnership will commission an updated Avelere report, available in 2021, that has been very important in past years to convince the Legislature that the protected class policy has no impact on prescription drug costs. And subsequent to her briefing an important research paper was published in the American Journal of Managed Care which confirmed that generic drugs are dispensed in the protected classes at the same rates as they are dispensed generally. This finding further negates a key argument that proponents of eliminating the protected classes use in that it shows there would be no cost savings associated with the removal of the protected classes by taking away what they argue is an incentive to prescribe more expensive name brand drugs.

ORGAN ALLOCATION POLICY

The Government Accounting Office (GAO) recently issued a report that discusses the changes in organ allocation policy that UNOS has implemented in the past several years. A very important part of this report concludes that the policies that UNOS created for this change were created in a very fair and open manner, with a great deal of community input from the professional groups to the interested public groups. As an adjunct to the GAO report, UNOS also released a report recently that cites an incremental increase in liver transplantation as a result of the new liver allocation activities that began about one year ago. These changes reflect the importance of the Final Rule in UNOS’s allocation policies.
Changes continue to be made to allocation policies across all of the solid organ categories. The latest changes will come in December, 2020, with the elimination of geographic borders for kidney, pancreas, and kidney-pancreas distribution. Changes have already been implemented for heart, lung, and liver allocation. The Senate Appropriations Committee however has recently released a package of spending bills for 2021 that impact transplantation by potentially keeping smaller geographic border in place during the period that Covid 19 travel restrictions impact transport availability and timing. This package is generally used in negotiations with the House leading up to approval of spending programs and is not expected to have longer term effects.

NEW RULE FOR ORGAN PROCUREMENT ORGANIZATION (OPO) PERFORMANCE MEASUREMENT

On November 20, the Centers for Medicare & Medicaid Services (CMS) finalized a rule designed to increase the supply of organs available for transplant in the United States. The rule enacts reforms of the Medicare Conditions for Coverage for Organ Procurement Organizations (OPOs). OPOs are non-profit organizations responsible for evaluating and procuring organs for transplant from deceased donors. These organizations also provide support to donor families, clinical management of organ donors, and professional and public education about organ donation. Currently, there are 58 OPOs in the United States, each assigned to its own Donation Service Area. The rule creates new measures designed to hold OPOs accountable for seeking and ensuring transplant of as many organs as possible. The first measure change is to the donation rate measure. The changes encourage OPOs to pursue all potential donors, even those who are only able to donate one organ. The second measure change is to the organ transplantation rate measure. OPOs will no longer receive credit for simply procuring an organ rather the organ must be actually transplanted. CMS will also be making outcome measure performance public to increase transparency. This will highlight OPOs that fall outside of the top 25% in donation and transplantation rates and will help OPOs identify areas for improvement.
For a fact sheet on the final rule (CMS-3380-F), visit: https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos To view the final rule (CMS-3380-F), visit: https://www.cms.gov/files/document/112020-opo-final-rule-cms-3380-f.pdf

November 2020

National Public Policy Report

CONTINUING ACTIVITIES WITH TRANSPLANTATION

Transplantation topics continue to be an important part of the news and the public agenda with important activities in the past several weeks.

THE PARTNERSHIP FOR PART D ACCESS

The regular monthly meeting of the PARTNERSHIP activities group met recently to keep its members informed on the latest legislative and departmental activities affecting open access to prescription drugs under the protected class policies on Medicare.
Catherine Finley from Thorn Run Partners, the long-time guiding member of the Partnership, updated the group on several points:
1.  The political and election activities for most of this year have kept the limelight from
seeing any substantive changes or recommendations to alter current policies that
affect the protected classes.
2.   The highly likely change in the Executive Branch will also slow down any potential
changes. However, the Partnership is committed to establishing contact with the
new Executive leadership team as soon as possible in 2021.
3.   The Partnership will commission an updated Avelere report, available in 2021,
that has been particularly important in past years to convince the Legislature that the protected
class policy has no impact on prescription drug costs. Changing the policy could cause
serious disruption in the ongoing mental and physical health of protected class patients.

THE NATIONAL COALITION FOR TRANSPLANT EQUITY (FORMERLY CODE)

Billy Wynne, the long-time manager of CODE and the NCTE, recently sent out two important emails with information about transplant and donation activities.
The Government Accounting Office (GAO) issued a report that discusses the changes in organ allocation policy that UNOS has implemented in the past several years. An important part of this report concludes that the policies that UNOS created for this change were created in a very fair and open manner, with a great deal of community input from the professional groups to the interested public groups.
Changes continue to be made to allocation policies across all the solid organ categories. The latest changes will come in December 2020, with the elimination of geographic borders for kidney, pancreas, and kidney-pancreas distribution. Changes have already been implemented for heart, lung, and liver allocation.
As an adjunct to the GAO report, UNOS also released a report recently that cites an incremental increase in liver transplantation because of the new liver allocation activities that began about one year ago. These changes reflect the importance of the Final Rule in UNOS’s allocation policies.
Mr. Wynne reported on legislative activities for the funding of organ donation and transplantation programs and activities. The Senate Appropriations Committee released a package of spending bills for 2021 that impact transplantation. This package is generally used in negotiations with the House leading up to approval of spending programs.

Don’t hesitate to contact TRIO-Oklahoma Public Policy Committee with your questions and comments.

TRIO-Oklahoma’s committee on advocacy and public policy will discuss issues of importance to transplant patients and then post advocacy and public policy information on this page. We greatly value the input of all TRIO-Oklahoma members.