HealthCare Roundtable e-News – April 25, 2019

Judiciary Committee to Review CREATES and Pay for Delay Bills in Upcoming Markup

According to committee member aides, the House Judiciary is planning to hold a markup in the coming weeks for lawmakers’ considerations. Among the bills being reviewed is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act and Pay for Delay, which both aim for stricter rules on anti-competitive behavior in the drug-making industry.

Judiciary Committee Chair Jerrold Nadler (D-N.Y.) previously stated that he had been working on introducing a bill that would prohibit brand drug-makers from bribing or forcing generic companies to abandon their patents, although that bill has yet to be introduced. (InsideHealthPolicy).

Last month, a House health panel reviewed both CREATES and Pay for Delay bills in an effort to tackle work on prescription drug legislation. Rep. Peter Welch (D-Vt.), among those in the House supporting Pay for Delay, noted the “abuse is on us if we let it continue…these companies get away with it, but only if we let them do it.” Both bills received bipartisan-backed changes and will be reviewed once the committee has decided on a date.

House Republicans Introduce Bills to Codify AHP Rules

Earlier this month, Senate Budget Committee Chair Mike Enzi (R-Wyo.) unveiled legislation that will aim to ensure small businesses and self-employed individuals continue to have access to association health plans (AHPs) after a federal judge struck down key provisions of the Trump administration’s AHP expansions last year.

While the administration is expected to appeal the judge’s decision, the bill would codify the rule and would ensure AHP beneficiaries maintain the same patient protections as those plans offered by large employers. Other members of the House have also introduced a companion legislation known as Association Health Plans Act of 2019, which also looks to expand lower-cost health care options.

“This strategy is working — in North Texas, several chambers of commerce already have begun offering health plans to their members through the North Texas Employer Health Plan Cooperative. All of the plans in this co-op provide coverage for maternity care, prescription drugs, and mental health and substance use disorder care,” said Rep. Michael Burgess (R-Texas). (InsideHealthPolicy).

Democratic Presidential Candidates Reintroduce ACA Reform Bill

Last week, several Democratic Presidential contenders reintroduced a bill to reform ACA exchanges. Sens. Elizabeth Warren (D-Mass.), Kamala Harris (D-Calif.), Kirsten Gillibrand (D-N.Y.), Amy Klobuchar (D-Minn.) and Cory Booker (D-N.J.) are among the sponsors of the bill, titled the Consumer Health Insurance Protection Act, which aims to tackle “unreasonable” premium increases, require short-term plans to meet ACA standards, block association help plans and guarantee cost-sharing reductions payments. (InsideHealthPolicy).

“Congress can’t sit on the sidelines while the President tries to take away Americans’ health care. That’s why I led a resolution supported by every Senate Democrat that directs the Trump administration to reverse course and defend our health care law. But defending the law is only the start,” Sen. Jeanne Shaheen (D-N.H.) said in an address last week. (InsideHealthPolicy).

In recent months, House Speaker Nancy Pelosi (D-Calif.) and Minority Leader Chuck Schumer (D-N.Y.) have been encouraging Democratic lawmakers to continue to bolster policies protecting the Affordable Care Act. Previously, each of the candidates co-sponsoring the bill — with the exception of Klobuchar — had also supported Sen. Bernie Sanders’ (I-Vt.) “Medicare for all” bill, although the shift in focus seems appropriate while campaigning for the 2020 election is still in full swing. (InsideHealthPolicy).

Bipartisan Drug Bills Backing Generics and Biologics Protections Introduced

Three new pro-generic bills supporting a quicker push for approvals of generics and insulin biosimilars were introduced to the Senate last week. The Reforming Ever-greening and Manipulation that Extends Drug Years (REMEDY) Act, the Protecting Access to Biosimilars Act, and the Ensuring Timely Access to Generics Act have so-far seen support from lawmakers on both sides of the aisle. (InsideHealthPolicy).

The REMEDY Act, co-sponsored by Sens. Dick Durbin (D-Ill.) and Bill Cassidy (R-La.), aims to support intellectual property protections of brand-name drug companies while also removing the incentive for the companies to sue non-competitive patents. (InsideHealthPolicy). Durbin stated in a press release that the bill would “increase competition and help reduce drug costs by curbing patent manipulation by brand-name drug makers.”

The Protecting Access to Biosimilars Act, supported by Cassidy and Sen. Tina Smith (D-Minn.), will oversee insulin regulations and biologics market protections, and the Ensuring Timely Access to Generics Act, which also received bipartisan support, will enable the FDA to be able to approve or reject citizen petitions in regard to generics approval delays. (InsideHealthPolicy).