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ML Strategies Health Care Preview - Week of February 4, 2019

The long-awaiting safe harbor proposed rule was published last week as the Administration looks to get out in front of the drug pricing debate that is sure to shape the 116th Congress. Under the proposed rule, rebates offered by manufacturers to Part D plans, Medicaid managed care organizations (MCO), and pharmacy benefit managers (PBM) would not receive safe harbor protection under the Anti-Kickback Statute. Additionally, it would create a new safe harbor for prescription drug discounts offered directly to patients, as well as fixed fee service arrangements between drug manufacturers and PBMs.

The real-life effect of the proposal on lowering out-of-pocket costs for prescription drugs remains unclear. HHS ran a number of projections that found anywhere from an 8 to 22 percent increase in premiums for patients not in low- income subsidized plans. The proposal was largely met with skepticism from key Democrats who would like to see the government take more direct action on manufactures lower prices.

Of note, Democrats in both chambers are preparing investigations into various practices of drug manufacturers. Senator Bernie Sanders is reportedly eyeing price hikes by Catalyst Pharmaceuticals. Sanders requested the company answer 16 questions by February 18th. House Democrats, led by E&C Chairman Frank Pallone and Rep. Diana DeGette, who chairs the E&C Oversight Subcommittee, requested information from Eli Lilly regarding access and the cost of insulin.

Additionally, House Oversight Committee Chairman, Elijah Cummings, sent letters to a dozen manufacturers requesting detailed information about their pricing practices. As both parties dive into drug pricing proposals and

investigations, it’s important to monitor the nuances within each proposal and what proposals, if any, have broad support.


California and 16 other states, along with the Administration, have requested that the Texas v. Azar case, which in December ruled the Affordable Care Act unconstitutional, be expedited to bring the case before the Fifth Circuit Court of Appeals by July 2019. Expediting the case could mean a case before the Supreme Court sometime in 2020, ensuring health care will remain atop the legislative and political agenda for the foreseeable future, especially as we enter the 2020 election cycle.

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume IX, Number 35


About this Author

Connie Garner ML Strategies Disability & Education Policy VP
ML Strategies - Vice President for Disability Policy & Education Policy

As Vice President for Disability Policy & Education Policy at ML Strategies, Connie leverages legislative, health care, government agency, and nonprofit and private sector consulting experience to help clients develop strategies on disability issues and education issues affecting their employees and businesses.

Connie is widely recognized as a national policy leader on disability, health care, and education issues. For 17 years, she was Policy Director for Disability and Special Populations to the US Senate Committee on Health, Education, Labor and Pensions (HELP), where she...

Frank Guinta ML Strategies VP
Senior Vice President of ML Strategies/US

Frank is based in our Washington, DC office and is Senior Vice President of ML Strategies.

Prior to joining the firm, Frank represented New Hampshire’s 1st congressional district in the US House of Representatives. He served for two nonconsecutive terms, from 2011 to 2013 and from 2015 to 2017. During his time in Congress, Frank served on several House committees. During his most recent term, he was a member of the Committee on Financial Services and served on its Financial Institutions and Consumer Credit as well as its Monetary Policy and Trade sub-committees. Previously he served on the Committee on the Budget, the Committee on Oversight and Government Reform, and the Committee on Transportation and Infrastructure.

Frank was also co-founder and co-chair of the House’s Bipartisan Task Force to Combat the Heroin Epidemic, which successfully pushed for the passage of legislation that became part of the Comprehensive Addiction and Recovery Act (CARA). He is currently a member of the National Advisory Board of the Addiction Policy Forum, a partnership of organizations, policymakers, and stakeholders committed to increasing addiction awareness and improving national policies.

In 2005, Frank defeated a three-time incumbent to become mayor of Manchester, New Hampshire, the state’s largest city. At the time of his election, Frank was Manchester’s youngest mayor in over 100 years. He is credited with introducing community policing policies that helped control crime in the city, and with reducing taxes. In 2007, he was elected to a second term. During Frank’s tenure, Manchester was cited by several national publications for its recession-busting economic development, responsible fiscal philosophy, and favorable quality of life.

Prior to becoming mayor of Manchester, Frank was senior policy advisor to US Congressman Jeb Bradley. From 2000 to 2004, he served in the New Hampshire House of Representatives. Earlier he was elected to serve on Manchester’s Board of Aldermen, where he represented Ward 3. Frank also had a successful career in the insurance industry, and ran his own insurance consulting firm.


  • University of New Hampshire (MIP)
  • Assumption College (BA)


  • Chamber of Commerce, Spirit of Enterprise Award
  • NFIB, Guardian of Small Business
  • ABC, Legislator of the Year
  • Healthcare Leadership Council, Champion of Healthcare Innovation
  • National Association of Community Health Centers, Distinguished Community Health Advocate Award
  • Change Direction NH, Champion of Mental Health
  • National Association of Police Organizations, Outstanding Support of American Law Enforcement Award
  • Association of Mature American Citizens, Friend of AMAC Award
  • National Retail Federation, Hero of Main Street Award
  • Bi-State Primary Care Association, Community Health Center Champion Award
  • The Humane Society of the United States, Legislative Leader Award


  • Member, National Advisory Board, Addiction Policy Forum (2017 – Present)
  • Chairman, IBC-NH Independent Business Council (2013 – 2014)
Alexander Hecht, Vice President of Government Relations, Mintz Levin law Firm
ML Strategies - Executive Vice President & Director of Operations

Alex is Executive Vice President & Director of Operations, ML Strategies, Washington, DC. He is an attorney with more than 10 years of senior-level experience in Congress and trade associations.

Alex assists clients with their legislative and regulatory needs on a wide range of issues, including health care, telecommunications, the Telephone Consumer Protection Act (TCPA), technology, energy, and federal procurement. Prior to joining ML Strategies, Alex served for over six years as chief counsel for Senator Olympia J. Snowe (R-ME) on the US Senate Committee on Small Business...

Eli Greenspan ML Strategies Mintz
Manager of Government Relations

Prior to joining ML Strategies, Eli was a legislative correspondent for US Senator Martin Heinrich (D-NM), where his experience included health care, education, child welfare, social security, food assistance, and poverty issues specifically as they relate to the Affordable Care Act, Medicare, and Social Security. Previously, Eli served as a legislative intern with Senator Heinrich. He also served as a legislative intern with Senator Dick Durbin (D-IL), where he worked on issues related to education, health, and commerce. Eli has also served as an intern at a political...