All 12 Prescription Drug & ACA 2.0 "mini-bills" Pass Out Of Committee!

Last week I noted that the House Energy & Commerce Committee held all-day hearings a dozen healthcare-related bills, half of which are related to prescription drug regulation & pricing, the other half of which cover about half of the provisions of the larger ACA 2.0 bill also rolled out by the House Dems last week.

Late last night, the E&C committee was burning the midnight oil (seriously...they were working on it past midnight) during the "markup langage" part of the process...and ended up voting to approve all 12 bills:

E&C CHAIRMAN PALLONE ON PASSAGE OF 12 BILLS TO LOWER HEALTH CARE AND PRESCRIPTION DRUG COSTS FOR CONSUMERS
Apr 4, 2019

Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) released the following statement today after 12 bills to lower health care and prescription drug costs for consumers were favorably reported to the full House of Representatives:

“Today the Energy and Commerce Committee took a big step in following through on Democrats’ commitment to the American people to lower health care and prescription drug costs. We were able to move forward in a bipartisan way on bills that will help bring generic drugs to market faster, which will make medications more affordable. We also passed bills that will lower health care costs, expand access to care, and protect people with pre-existing conditions by reversing the Trump Administration’s sabotage of the Affordable Care Act. I look forward to bringing these bills to the House Floor in the near future.”

The Committee favorably reported the following bills:

• H.R. 1781, the “Payment Commission Data Act of 2019,” introduced by Reps. Buddy Carter (R-GA), Tom O’Halleran (D-AZ), Tom Rice (R-SC), Jimmy Panetta (D-CA), Greg Gianforte (R-MT), and Peter Welch (D-VT), provides the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC) with access to drug pricing and rebate data in order for these independent, non-partisan commissions to help Congress better understand the true costs of prescription drugs to consumers and taxpayers. The bill was passed by voice vote.

• H.R. 938, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019," introduced by Reps. Kurt Schrader (D-OR) and Buddy Carter (R-GA), would discourage parking of 180-day exclusivity by a first generic applicant that is blocking the approval of other generics. The bill was passed by voice vote.

• H.R. 1520, the "Purple Book Continuity Act of 2019," introduced by Rep. Anna G. Eshoo (D-CA), would codify publication of the patents of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book, specify that the Purple Book should be published electronically on FDA’s website and updated routinely, and direct FDA to consider the types of patents that should be listed in the Purple Book. The bill was passed by voice vote.

• H.R. 1503, the "Orange Book Transparency Act of 2019," introduced by Rep. Robin Kelly (D-IL), would help to ensure that the Orange Book is accurate and up-to-date, by requiring manufacturers to share complete and timely information with FDA, as well as ensuring that patents listed in the Orange Book are relevant to the approved drug product. Patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed promptly. The bill was passed by voice vote.

• H.R. 1499, the "Protecting Consumer Access to Generic Drugs Act of 2019," introduced by Rep. Bobby Rush (D-IL), would make it illegal for brand-name and generic drug manufacturers to enter into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep a generic equivalent off the market. The bill was passed by voice vote.

• H.R. 965, the "Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019," introduced by Reps. David Cicilline (D-RI), Jim Sensenbrenner (R-WI), Jerrold Nadler (D-NY), Doug Collins (R-GA), Peter Welch (D-VT), and David McKinley (R-WV), would establish a process by which generic manufacturers could obtain sufficient quantities of brand drug samples for testing thereby deterring gaming of safety protocols that brand manufacturers use to delay or impede generic entry. The bill passed by a vote of 51-0.

The first six were the prescription drug bills, and as you can see, several were bipartisan. Five were by voice vote, the last one was roll call 51-0...not sure why that was necessary but whatever.

It was the ACA 2.0-related bills, of course, where partisanship kicked in; this is where the Democrats retaking control of the House makes a big difference:

• H.R.1385, the “State Allowance for a Variety of Exchanges (SAVE) Act,” introduced by Reps. Andy Kim (D-NJ) and Brian Fitzpatrick (R-PA), would provide states with $200 million in federal funds to establish state-based Marketplaces. Under current law, federal funds are no longer available for states to set up state-based Marketplaces. The bill was passed by a vote of 29-22.

Once again: This is the only one of these six ACA bills with bipartisan support.

• H.R.1386, the “Expand Navigators’ Resources for Outreach, Learning, and Longevity (ENROLL) Act,” introduced by Rep. Kathy Castor (D-FL), would provide $100 million annually for the Federally-Facilitated Marketplace (FFM) navigator program. The bill would reinstate the requirement that there be at least two navigator entities in each state and would require HHS to ensure that navigator grants are awarded to entities with demonstrated capacity to carry out the duties specified in the Affordable Care Act. The bill would also prohibit HHS from considering whether a navigator entity has demonstrated how it will provide information to individuals relating to association health plans or short-term, limited-duration insurance plans. The bill was passed by a vote of 30-22.

• H.R. 987, the “Marketing and Outreach Restoration to Empower (MORE) Health Education Act of 2019,” introduced by Rep. Lisa Blunt Rochester (D-DE), would restore outreach and enrollment funding to assist consumers in signing up for health care, which has been slashed by the Trump Administration. The bill was passed by a vote of 30-22.

• H.R. 1010, a bill to provide that the rule entitled “Short-Term, Limited Duration Insurance” shall have no force or effect, introduced by Rep. Kathy Castor (D-FL), would reverse the Trump Administration’s expansion of junk insurance plans, also known as short-term, limited-duration insurance plans. The bill was passed by a vote of 30-22.

• H.R. 986, the “Protecting Americans with Preexisting Conditions Act of 2019,” introduced by Rep. Ann M. Kuster (D-NH), would require the Trump Administration to rescind the Section 1332 guidance of the ACA promulgated in October of 2018 that would undermine the law’s consumer protections. The bill was passed by voice vote.

Now that's interesting...Trump's CMS issued guidance which would basically strip away many of the essential health benefit requirements of ACA-compliant plans among other things. Very interesting that this one was passed by voice vote instead of roll call. I guess the GOP members didn't want to be put on the record as voting to weaken those provisions...too bad most of them had already effectively voted to kill the entire ACA earlier in the day...

• H.R. 1425, the “State Health Care Premium Reduction Act,” introduced by Reps. Angie Craig (D-MN) and Scott Peters (D-CA), would provide $10 billion annually to states to establish a state reinsurance program or use the funds to provide financial assistance to reduce out-of-pocket costs for individuals enrolled in qualified health plans. The bill also requires CMS to establish and implement a reinsurance program in states that do not apply for federal funding under the bill. The bill was passed by a vote of 30-22.

The saddest part about this one is that not only was it GOP Senator Susan Collins' idea to add a $10 billion/year reinsurance program during the ill-fated Alexander-Collins/Alexander-Murray discussions last year, CMS Administrator Seema Verma herself is a big fan of reinsurance (who would've figured?). Yet it appears that practically every Republican still voted against it last night.

No matter...all twelve go on to the full House next regardless.