Washington Update, November 2019

Washington Update

By Johanna Gray and Ellen Riker

Drug Pricing
Congress has been working for the last several months to consider comprehensive drug pricing proposals –there are three main versions that have been released by the Senate Health, Education, Labor and Pensions (HELP) Committee, Senate Finance Committee, and House Democrats. The House version (HR 3) has passed out of all three House Committees and was expected to be voted on by the full House earlier this fall, but the timing keeps being pushed back – now to December. On the Senate side, the Finance Committee is working on a new draft of their bill and the staff said in a recent meeting that they are trying to strengthen the bill’s benefits for patients. We will review this new version and will assess its impact on HTCs and the bleeding disorders community.

Congressional staff are hoping to reach agreement on drug pricing so that policies could be included in an end-of-the-year package in December (see below for more details). But it remains unclear if there is enough support for any proposals to pass either chamber, much less consensus on a set of policies that could have enough support to pass both chambers and be signed into law by President Trump.

Congress has not been able to pass full-year funding bills yet, but rather has passed two short-term continuing resolutions (CRs). The current bill to fund the government goes until December 20th. The sticking points have been that the House and Senate can’t agree on the top-line funding levels for each bill (how much is allocated to the Labor-HHS-Education bill vs. the Defense bill) nor how to handle a handful of difficult policy issues, such as the border wall and family planning funding. Congressional leaders are continuing to negotiate and hope to agree on these sticky issues so that they can pass negotiated bills before the end of the year (rather than another CR). These bills would provide funding for the federal hemophilia activities at the CDC, HRSA and NIH for the rest of the year. These bills are also the likeliest vehicle for drug pricing and other policies that Congress wants to enact this year.

CMS Releases Final Hospital Outpatient Payment Rule for 2020 with 340B Cuts
The Medicare Hospital Outpatient Prospective Payment System Final Rule was released on November 1, 2019. Included in the rule is a provision to extend the reduction in payment for 340B drugs at ASP-22.5 percent for 2020, for drugs furnished in hospital outpatient departments and off-campus provider-based departments (non-excepted). Critical access hospitals, rural sole community hospitals, children’s hospitals and PPS-exempt cancer hospitals remain excepted from the payment reduction. Hospitals subject to the payment reduction must continue to use claim-level modifiers when 340B drugs are used.

This policy is currently subject to a lawsuit, which CMS is appealing. CMS decided to continue the payment reduction until the court decision is finalized. The agency plans to survey hospitals on actual acquisition costs for 340B drugs shortly and states that it is relying on this survey to establish an alternative to ASP-22.5 percent or use another option such as ASP+3 percent, depending on the outcome of the court case.

Also in this Issue…

Notes from Joe
· Back to the Future

Payer Update
· Patient Data: Who Owns It, How Do You Use It, and Why Should You Care?

Legal Update
· Supporting Patients while Steering Clear of Fraud

Notes from the Community
· Update from the Hemophilia Alliance Foundation

Alliance Update
· Alliance Operations Update
· 2020 Meeting Schedule

Team Alliance Contact Information

We work for you! Please don’t hesitate to contact any of us with any questions or concerns:

Name Email Phone
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Joe Pugliese joe@hemoalliance.org 215-439-7173
Sean Singh sean@hemoalliance.org 727-388-7326
Jeff Blake jeff@hemoalliance.org 317-657-5913
Jeff Amond amond@hemoalliance.org 608-206-3132
Johanna Gray, MPA jgray@artemispolicygroup.com 703-304-8111
Elizabeth Karan ekaran@feldsmantucker.com 612-202-3240
Kimberly Wolverton Lackman kimberly@hemoalliance.org 813-400-6710
Roland P. Lamy, Jr. roland@hemoalliance.org 603-491-0853
Dr. George L. Oestrich, Pharm.D., MPA george@gloetal.com 573-230-7075
Ellen Riker eriker@artemispolicygroup.com 202-257-6670
Mark Plencner mark@hemoalliance.org 701-318-2910
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Theresa Parker theresa@hemoalliance.org 727-688-2568
Karen Bowe karen@hemoalliance.org 717-571-0266
Joel Bellucci webmaster@hemoalliance.org 727-504-0491