HealthCare Roundtable e-News – April 9, 2019

  • House E&C Committee Approves Bipartisan Drug Pricing Bills
  • House Ways and Means Committee Expected to Vote on Drug Pricing Bills This Week
  • CMS Offers Transition Period Under Administration’s Proposed Rule Eliminating Safe Harbor Protections
  • House E&C Committee Approves Bipartisan Drug Pricing Bills

    On Wednesday, the House Energy & Commerce Committee advanced several bills to be voted on by the full chamber, an effort showing the group’s commitment to lower consumer drug prices. Among the bills were also several proposals aimed at strengthening the Affordable Care Act only a few weeks after the Trump Administration vowed to cut the program after the 2020 election.

    The bills tackling drug costs for consumers and bolstering generic competition garnered the most bipartisan support. Among the most anticipated bills is the Roundtable-supported CREATES Act of 2019, which aims to increase competition by cracking down on brand-name drug manufacturers using tactics to keep generic manufacturers from entering the market. The bill will also enable generic drug companies to sue brand-name drug companies for withholding product samples.

    Among the bills aimed at protecting ACA is the Protecting Americans with Pre-Existing Conditions Act of 2019, a bill designed to lower healthcare premiums and ensuring coverage for individuals who suffer from pre-existing conditions. Rep. Angie Craig (D-MN) and other members of the Democratic leadership announced the bill last month after a Texas federal judge ruled that the Affordable Care Act was unconstitutional. In February, Craig had also announced the State Health Care Premium Reduction Act, which aims to address the affordability of health insurance by lowering premiums, and was approved by the committee last week.

    House Ways and Means Committee Expected to Vote on Drug Pricing Bills This Week

    The House Ways and Means committee is expected to vote on several drug pricing bills this week, as Democrat and Republican members seek to finalize legislation calling for more transparency and pricing disclosures. There are currently several pieces of legislation, each bipartisan, that are expected to be marked up this week.

    The first bill, known as the SPIKE Act of 2019, comes from Reps. Steven Horsford (D-NV) and Tom Reed (R-NY) requiring drug companies to publicly justify any substantial price increases of 10% over one year, 25% over three years, or totaling more than $26,000. The bill would require manufacturers to submit justification explaining the causes of the increase or high launch price, as well as information on additional expenses from developing, manufacturing or marketing the drug.

    Among the other bills expected to be voted on this week is Reps. Abigail Spanberger (D-VA) and George Holding’s (R-NC)proposal to require pharmacy benefit managers to report information on aggregate rebates, and Reps. Lloyd Doggett (D-TX) and Vern Buchanan’s (R-FL) bill that would improve methods for reporting sales price information. Reps. Judy Chu (D-CA) and Devin Nunes (R-CA) are also expected to present the Samples Act, H.R. 2604, which calls on companies manufacturing drugs and health devices to report on the total value of any and all free samples given to health care providers.

    CMS Offers Transition Period Under Administration’s Proposed Rule Eliminating Safe Harbor Protections

    Last week, CMS administrator Seema Verma announced that the agency will offer pharmacy benefit managers a two-year transition period to prepare for the proposed rule to eliminate safe harbor protections under the Anti-Kickback Statute. The proposal would establish instead a new safe harbor enabling pharmaceutical manufacturers to offer reduced prices on products when they are applied at the point-of-sale, a statement from the agency said.

    “If there is a change in the safe harbor rules effective in 2020, CMS will conduct a demonstration that would test an efficient transition for beneficiaries and plans to such a change in the Part D program,” Verma wrote in the bulletin last week.

    House Energy & Commerce Chair Rep. Frank Pallone (D-NJ) criticized the rule for lacking provisions that would require manufacturers to reduce their list prices. Matt Eyles, CEO of America’s Health Insurance Plans, stated that the proposed changes“could result in a premium increase of 25% and a $100 billion giveaway to Big Pharma.”