ACA Lawsuit Update

The U.S. Court of Appeals for the 5th Circuit has granted the Department of Justice’s request that appeal proceedings in the Affordable Care Act (ACA) lawsuit be temporarily halted due to the partial government shutdown and consequent funding lapse affecting the agency. Attorneys general from a group of Democratic states have filed an appeal challenging a lower court’s ruling that the law is unconstitutional. The law will remain in effect until the conclusion of the appeals process.

The House of Representatives passed another measure last week to permit House counsel to intervene in the lawsuit. H.Res. 6 passed by a vote of 235-192, with GOP Reps. John Katko (N.Y.), Brian Fitzpatrick (Pa.), and Tom Reed (N.Y.) joining Democrats in support of the resolution. The House had previously passed the same provision as a part of a rules package at the start of the 116th Congress.

House Passes PAHPA/OTC Legislation

The House of Representatives passed the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 last week. The $7 billion reauthorization measure for emergency pandemic-prevention programs, which includes an overhaul of the over-the- counter (OTC) drug regulatory framework, passed by a vote of 401-17. Most of the emergency health programs covered by H.R. 269 expired at the end of September. The legislation would reauthorize them through fiscal year (FY) 2023. Similar legislation was passed by the House at the conclusion of the 115th Congress but was blocked in the Senate.

The House also passed H.R. 259 last week, which would provide $112 million in funding to continue projects under the Money Follows the Person Rebalancing Demonstration Grant for FY 2019. The bill would be paid for by reducing Medicaid funding for states that don’t have asset verification programs for Medicaid eligibility determination beginning in 2021.

Democrats Introduce Package of Drug Pricing Legislation

Democrats in the House and Senate, led by Sen. Bernie Sanders (D-Vt.), have introduced a package of drug pricing legislation. The package includes the reintroduction of a bill that would tie drug prices to the cost paid in other countries, an idea similar to what the administration has proposed in its International Pricing Index (IPI) regulation. Under the Prescription Drug Price Relief Act (S.102/H.R. 465), the U.S. Department of Health and Human Services (HHS) would be responsible for ensuring that Americans do not pay more for a product than the median price of Canada, U.K., France, Germany, and Japan. The Affordable and Safe Prescription Drug Importation Act (S. 97/H.R. 447) would legalize drug importation from Canada and other major countries. The Medicare Drug Price Negotiation Act (S. 99/H.R. 448) would allow Medicare to negotiate prices in Part D. Sanders was joined by Reps. Elijah Cummings (D-Md.), Ro Khanna (D-Calif.), Peter Welch (D-Vt.), Joe Neguse (D-Co.), Ilhan Omar (D-Minn.), and other cosponsors in unveiling the package. They called on the President to back the legislation.

In related news, HHS Secretary Alex Azar has requested a meeting with Rep. Cummings, and the two plan to meet this week to discuss the issue of drug pricing.

Klobuchar, Grassley Introduce Bipartisan Prescription Drug Cost Legislation

Sens. Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) have introduced a bill aimed at curbing so-called pay-fordelay tactics allegedly used to deter market entry by generic manufacturers. Klobuchar and Grassley also introduced legislation last week that would allow Americans to import prescription drugs from Canadian pharmacies. The Safe and Affordable Drugs from Canada Act of 2019 would direct the FDA to permit personal importation of pharmaceuticals – excluding biologics and certain controlled substances like opioids – from approved Canadian pharmacies. Products could be purchased in supplies of 90-days or less and could not be resold. While Grassley opposes proposals to negotiate prices in Part D, he has said he will make drug prices a top priority as chairman of the Senate Finance Committee. He has also promised action on the CREATES Act, which would adjust risk evaluation and mitigation strategy (REMS) requirements with the aim of easing generic drugs’ entry onto the market.

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