Legislative Update: Week of December 16, 2019
On Friday, the Governor signed the FY2019 Supplemental Budget into law, which included language in Section 15 to extend the sunset on copay assistance 12 months to January 1, 2021.
The Massachusetts Health Policy Commission (HPC) and the Executive Office of Health and Human Services (EOHHS) held hearings on Friday on the proposed regulations implementing the MassHealth drug pricing law passed earlier this year as part of the state’s FY2020 budget. MassBio submitted comments regarding the EOHHS draft regulations and will be submitting comment to the HPC later this week.
Prior to the hearing, it was announced that the HPC hired the former Director of CER Policy Development at ICER to take the role of Associate Director of Pharmaceutical Pricing. In this role, she will be implementing the HPC’s new authority to control drug costs/determine drug value in MassHealth, as outlined in the FY2020 budget.
In Federal news, a new, comprise trade bill to replace NAFTA that was unveiled by Congressional leadership on Tuesday did not include language originally proposed by the Trump Administration that would have provided additional patent protection in Canada and Mexico for biologic medicines developed in the United States. The initial agreement would have extended exclusivity in Canada and Mexico for 10 years, but that provision was ultimately stripped from the final version. The agreement has not yet been ratified by the House. MassBio President and CEO issues the below statement on the language:
“The U.S. and Massachusetts in particular have been leaders in biologics innovation, creating new therapies for some of the most debilitating diseases impacting patients. Development of these new treatments and cures is dependent upon innovators being properly rewarded and their intellectual property being protected. The removal of enhanced IP protections for biologic medicines in the revised USMCA promises to jeopardize this ingenuity, opening the door for foreign free-riding on American medical innovation – something President Trump promised to end.”
On Thursday, the United States House of Representatives passed H.R. 3, the Lower Drug Costs Now Act, as amended, in a 230 to 192 vote – primarily along party lines. It will now move to the Senate where it will await further action. Prior to the vote, Democrats added additional provisions to the bill, increasing the minimum number of drugs that could be negotiated each year to 50, and implementing additional means to block drug manufacturers from raising prices more than inflation. MassBio President and CEO Bob Coughlin issued the below statement on the House passage of H.R. 3:
“Members of the House who voted to pass H.R. 3 are now on record as supporting fewer new medicines coming to the market each year. They seem to believe this is a good thing and that reducing biopharmaceutical companies’ revenues by more than $400 billion will simply lead to companies forgoing development of “me too” drugs or low-value therapies. In fact, if this bill comes law, the opposite is a much more likely outcome. H.R. 3’s use of an international price index as the cap on negotiated drug prices in Medicare means the research into the hardest to crack scientific questions will no longer happen because the return on investment no longer exists. Companies with newly restricted revenues will likely steer toward proven, safe science and away from the tougher R&D. And investors are likely to severely limit new funding toward smaller, private, pre-revenue companies that tackle the riskiest, most expensive work necessary to find the next therapy or cure for diseases with limited to no existing treatments like Alzheimer’s, Parkinson’s, pancreatic cancer, and heart disease.”
Also on Thursday, the Senate confirmed Dr. Stephen Hahn as the next FDA Commissioner in a vote of 72 to 18.
On Monday, the White House announced that the USMCA Trade Agreement was delivered to Congress. As a result, the House Ways and Means Committee will meet to discuss the implementation bill, HR5340, on Tuesday.