House Judiciary Committee: “TBA Markup on CREATES Act, Pay-for-Delay Legislation”
The House Judiciary Committee is planning a markup on the CREATES Act and pay-for-delay legislation. The date of the markup is to be announced. Last month, Judiciary Committee Chair Jerrold Nadler (D-NY) said he intended to introduce a bill to prohibit deals in which a brand drug maker pays a generic competitor to abandon a patent challenge, delaying their entry into the market. Rep. Nadler has not yet introduced the bill. The House Energy & Commerce Committee passed a version of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act with bipartisan amendments earlier this month.


Schakowsky, Rooney Reintroduce Drug Price Justification Bill
On April 18, Reps. Jan Schakowsky (D-IL) and Francis Rooney (R-FL) reintroduced a bill that would require manufacturers to provide the Department of Health and Human Services (HHS) with advance notice and justification of price hikes on prescription drugs. The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2019 forces drug manufacturers to submit a pricing information and justification report to HHS at least 30 days in advance of drug price increases larger than 10 percent of the drug’s price over one year, or 25 percent over three years.

Pallone, Shalala Introduce Bill to Ban Online E-Cig Sales, Raise Minimum Purchase Age
On April 16, House Energy & Commerce Committee Chair Frank Pallone (D-NJ) and Rep. Donna Shalala (D-FL) introduced a bill allowing the Food and Drug Administration (FDA) to collect user fees for e-cigarettes, raise the minimum age to purchase tobacco to 21 and prohibit online sales of tobacco products. The bill also bans all characterizing tobacco product flavors, requiring the FDA to finalize rulemaking to implement graphic health warnings for cigarette packages, and holds all deemed tobacco products to the same advertising and sales requirements applied to combustible cigarettes. Monitor the bill here.

Bipartisan Bill Introduced to Exempt APMs from Stark Law Provisions
On April 10, Reps. Raul Ruiz (D-CA), Larry Bucshon (R-IN), Ron Kind (D-WI) and Kenny Marchant (R-TX) reintroduced the Medicare Care Coordination Improvement Act of 2019 in the House. The bill provides to alternative pay models the same physician self-referral waivers that accountable care organizations were granted by the Affordable Care Act (ACA). The bill also gives providers working to develop a new demo for a better alternative payment model (APM) a three-year waiver. Moreover, the bill lets APMs and those testing potential APMs get around the Stark law’s volume or value prohibition.

Read more on healthcare policy on the McGuireWoods Consulting website.