At the Table – August 2020

CMS Returns to Medical Alley to Announce Rule Targeting Patient Access to Innovative Technology

Yesterday, we were privileged to welcome Center for Medicare and Medicaid Services (CMS) Administrator Seema Verma, as well as U.S. Rep. Tom Emmer and leaders from several Medical Alley companies for a tour of University Enterprise Laboratories, and roundtable discussion on spurring innovation in healthcare. Joining the discussion were representatives from 3M, Allina Health, AtriCure, Boston Scientific, Mayo Clinic, Medtronic, Radwave Technologies, Syntiron, Zeptolife Technology, and UEL, who graciously hosted the event as well as participating in the discussion.

The roundtable followed CMS’ announcement of a new proposed rule, Medicare Coverage of Innovative Technology (MCIT), which would guarantee four years of coverage for breakthrough devices granted market authorization through the by the FDA. The Medical Alley Association supports increasing patient access to innovative and effective medical technologies that can improve outcomes and lower the cost of care, and this proposed rule change makes significant strides that direction. We look forward to hearing feedback on this proposed rule from our members and putting forward comments to improve the effectiveness of any final rule.

As the aim of this new rule is ultimately increasing access to innovative technologies for patients, it is fitting that this announcement took place in Medical Alley, The Global Epicenter of Health Innovation and Care™.

Medical Alley Support for the IGNITE American Innovation Act

In Early August, U.S. Rep. Phillips introduced the “IGNITE American Innovation Act,” which would provide critical liquidity to emerging health technology and care companies adversely impacted by COVID-19.

Despite Congress’ historic efforts to stabilize the economy, the relief efforts have limited applicability for capital intensive companies without taxable income. The IGNITE American Innovation Act gives pre-profit companies access to up to a combined total of $25 million in refundable tax credits providing them desperately needed liquidity to get through the pandemic. The bill would also:

  • Allow growth companies to monetize up to $100 million worth of accumulated net operating losses (NOLs) that were generated within the previous five years at the 21 percent corporate rate
  • Double the value for NOLs generated by products to prevent, diagnose, or treat COVID-19
  • Allow growth companies to monetize R&D credits
  • Double the value of R&D credits generated by research into products to prevent, diagnose, or treat COVID-19
  • Cap the total benefit of the credits at $25M

The Medical Alley Association and industry leaders applaud U.S. Rep. Phillips for his support for this legislation that provides immediate access to much needed capital for innovative companies located in Medical Alley and throughout the United States.

Medical Alley Urges Finalization of Stark Law and Anti-Kickback Statute Reforms

The Medical Alley Association wrote a letter to the White House and the Office of Management and Budget (OMB) urging a speedy review and release of new, final rules reforming the Stark Law and Anti-Kickback Statutes (AKS) regulations.

These rules were delivered to OMB on July 21, 2020 and are the product of significant public input, insight, and feedback from healthcare industry leaders, and an extensive notice rulemaking process that began with an initial request for information in 2018. The Administration selected Medical Alley as the location to formally announce the release of the draft rules, in October 2019.

Organizations throughout Medical Alley are already collaborating to create value-based arrangements that improve outcomes for patients while simultaneously lowering costs. These proposed regulations will allow agreements like those developing in Medical Alley to become the new standard for healthcare’s future, driving value and collaboration.

Disaster Loan Assistance Available for Business Affected by Civil Unrest

The U.S. Small Business Administration (SBA) approved Governor Walz’s request for disaster eligibility for businesses affected by civil unrest.

Businesses and residents affected by the civil unrest in Hennepin County from May 27 through June 8, can apply for low-interest disaster loans from the SBA   to cover uninsured or underinsured losses related to these events.

Anyone affected by these events – homeowners or renters, businesses and nonprofit organizations – is eligible to apply. Loans can cover physical damage for individuals and businesses affected, and economic injury that businesses suffered because of the disaster. Interest rates can be as low as 1.25% for homeowners and renters, 2.75% for nonprofit organizations, and 3% for businesses. Repayment terms can extend as long as 30 years.

Find more information on eligibility and terms here.

Minnesota’s Third Special Session

The third special session was a short one, lasting only one day. Minnesota Management and Budget (MMB) is now in the middle of a $1.2 billion bond sale from previous bonding authorization. According to MMB, this initiates a “quiet period” and prohibits the Legislature from passing a bonding bill or any bill that would impact the General Fund or the state’s indebtedness, so the August agenda was limited in scope.

The Legislature did take action on a few non-budget items. Like the previous two special sessions, the Republican-controlled Senate voted to end the governor’s emergency powers; again, the Democrat-controlled House reaffirmed the governor’s emergency powers, this time by rejecting a move to bring up a resolution aimed at ending them.

The Legislature took action to provide economic relief to disability service providers. They passed SSHF1/SSSF1, which would appropriate more than $30 million from the coronavirus relief fund for grants to those businesses. Legislators also used the one-day special session to make modifications to the police reforms passed in July; they pushed back the deadlines for officers to receive some types of mandated training, gave more time for law enforcement organizations across the state to submit data to the Peace Officer Standards and Training (POST) Board, and extended the time frame for the first meeting of a POST Board advisory council.

As part of the bond sale, MMB issued financial updates for the next biennium. MMB is now forecasting $4.7 billion deficit for fiscal years 2022/2023 and a $2.3 billion deficit for the current biennium of FY 2021/2022. The state has a budget reserve of $2.3 billion.

Keep your finger on the pulse of Medical Alley from anywhere with the ALLEY NEWSLETTER