Feature
Medical Alley Association Salutes Efforts to Align CMS & FDA on Breakthrough Technologies
GOLDEN VALLEY, MN – Shaye Mandle, President and CEO of the Medical Alley Association, applauds the introduction of HR 5009 in the U.S. House of Representatives as an opportunity to stimulate innovation and improve patient access to the newest therapies, stating:
“HR 5009 would make it possible for U.S. patients to have confidence in the ability to gain access to the newest and most effective therapies our innovators are creating. This legislation would require CMS to provide immediate transitional three-year coverage for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA.
“This critical window of three years will provide patients and innovators with a predictable model for access and reimbursement, while also providing CMS an opportunity to evaluate any additional data requirements for continued coverage.”
HR 5009 contains provisions that would also make improvements to the New Technology Add-on Payment (NTAP) program of CMS to further address and reduce existing disincentives to innovation and patient access.
State Policy News
Thursday, April 21 marks the third and final committee deadline for the Minnesota Legislature. This deadline applies to the major appropriation and finance bills, often referred to as omnibus bills. The Senate Finance Committee and the House Ways and Means Committee met at length this week to discuss and vote on provisions in their respective omnibus finance bills.
Week in review: Budget, Budget, Budget
The Senate DFL Majority revealed their budget targets this week, which propose to spend $789 million of the projected $900 million surplus. This spending is made up of $300 million in tax cuts and $489 million in new spending. The Senate will have ONE supplemental budget bill.
The House is opting for a different approach by combining the supplemental bills into three omnibus bills: 1. health and human services, state government finance and public safety; 2. Education and higher education; 3. Agriculture, environment, and Jobs.
The House and Senate also broke on Thursday night for a small mini break in observance of the Passover holiday. The Senate plans to meet this week Monday, Tuesday, Wednesday, and Thursday. To note, Senator Bakk indicated the Senate will take up the Supplemental Budget Bill on Thursday. If necessary, the Senate will have floor session on Friday.
Health and Human Services Omnibus Bills
The Senate Health and Human Services Budget Division heard their supplemental budget bill on Monday, April 18. The bill was recommended to pass and re-referred to the full Finance Committee where it was taken up for consideration on Thursday. The bill was recommended to pass as amended.
Notably absent, was the provision to eliminate the repeal of the Provider Tax. The current two percent tax is set to phase out as planned on December 31, 2019.
On the House side, after three days of hearings, the House Ways and Means Committee approved the final three supplemental budget bills on Thursday — health and human services, state government finance and public safety — merged them into one and sent HF3467 to the floor.
To note, the House HHS bill includes provisions to relieve medical assistance estate liens and funding for the Minnesota Family Residency program. It also included provisions to require the commissioner of human services to seek a federal waiver to allow MinnesotaCare enrollees access to advanced premium tax credits. For more details see the bill tracker below.
Federal Policy News
Medical Alley Association Salutes Efforts to Align CMS & FDA on Breakthrough Technologies
GOLDEN VALLEY, MN – Shaye Mandle, President and CEO of the Medical Alley Association, applauds the introduction of HR 5009 in the U.S. House of Representatives as an opportunity to stimulate innovation and improve patient access to the newest therapies, stating:
“HR 5009 would make it possible for U.S. patients to have confidence in the ability to gain access to the newest and most effective therapies our innovators are creating. This legislation would require CMS to provide immediate transitional three-year coverage for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA.
“This critical window of three years will provide patients and innovators with a predictable model for access and reimbursement, while also providing CMS an opportunity to evaluate any additional data requirements for continued coverage.”
HR 5009 contains provisions that would also make improvements to the New Technology Add-on Payment (NTAP) program of CMS to further address and reduce existing disincentives to innovation and patient access.
Hearings of Interest
For hearings of interest, learn more at the Minnesota State Legislature Combined Calendar.
