Health Policy Report

February 11, 2019

The Week in Review

Members of the Department of Homeland Security (DHS) Conference Committee resumed talks last week in hopes reaching a deal to avoid a second partial government shutdown. Despite optimism heading into the weekend about reaching a border security deal and funding the government past the Feb. 15 deadline, negotiators of the bipartisan border security Conference Committee indicated Sunday that the talks have hit an impasse over immigration detention policy and the total funding allocation. The talks have reportedly shifted away from a broader deal and toward a continuing resolution (CR) that would keep the government funded and provide negotiators with additional time.

Meanwhile, the Senate began consideration of a bipartisan federal lands package championed by conservation advocacy groups. The Natural Resources Management Act (S.47) would permanently reauthorize the Land and Water Conservation Fund (LWCF) — a program that uses federal oil and gas royalties from offshore drilling to fund acquisitions and easements of land and water — and also includes a host of provisions that would increase recreational access to federal lands and add to national parks and other land holdings. The Senate attempted to pass the lands package late last year in hopes of addressing the LWCF’s funding lapse, but was blocked by Sens. Mike Lee (R-UT) and Rand Paul (R-KY).

In the House, lawmakers overwhelmingly passed a bill (H.R. 840) that would make permanent the Department of Veterans’ Affairs (VA) Child Care Pilot Program. Lawmakers also passed a host of suspension bills out of the Judiciary and Transportation and Infrastructure Committees.

The Week Ahead

Congress will return to Washington today as lawmakers scramble to fund the government ahead of Friday’s deadline. While border security negotiations continue, it remains to be seen whether President Trump will sign a funding bill that does not include his border wall request. The President has criticized the Conference Committee’s negotiations as a “waste of time,” stating he would either shut the government down again or declare a national emergency that would circumvent Congress and tap into military construction funds for the wall. Meanwhile, White House Acting Chief of Staff Mick Mulvaney stated yesterday that he “absolutely cannot” rule out the possibility of another funding lapse, pinning the blame on Democrats for failing to act on President Trump’s border wall request.

On the floor, Senators are set to resume consideration of the comprehensive federal lands package (S.47) that would reauthorize the Land and Water Conservation Fund (LWCF). Following passage of the lands package, Majority Leader Mitch McConnell (R-KY) has queued up a confirmation vote on William Barr to be Attorney General of the United States. In the House, lawmakers will begin their legislative work week with consideration of five suspension bills out of the House Committee on Oversight and Government Reform.

State of the Union Highlights Drug Prices as President Pushes to End HIV, Childhood Cancer

Although health care wasn’t the primary focus of President Trump’s State of the Union Address last Tuesday, he took time to highlight his ongoing fight to lower medical costs and pharmaceutical prices. President Trump declared that lowering the cost of health care and prescription drugs as his next major health care priority, as well as protecting patients with pre-existing conditions. He claimed the Administration helped lower drug costs by 46 percent last year — a fact many have contested as “cherry-picking data” —and called on Congress to pass legislation supporting his plan to base some Medicare payments on European countries' prices. Additionally, he asked that Congress introduce a bill to “require drug companies, insurance companies, and hospitals to disclose real prices to foster competition and bring costs down.” Democrats criticized the President for failing to mention government price negotiation as a potential means of bringing costs down.

The President stated that his budget will include directives for Congress to pass funding to eliminate HIV within the next ten years. His proposal, outlined later by Health & Human Service Secretary Alex Azar, would increase access to medications for people living with HIV and focus prevention efforts in communities with the highest rates of HIV. Additionally, an announcement that the President would be asking Congress to allocate $500 million over the next ten years for pediatric cancer research drew praise from many, although it would only amount to roughly a ten percent increase in annual funding. House Speaker Nancy Pelosi (D-CA) reportedly called the funding insufficient. The President also congratulated his Administration and Congress for eliminating the “very unpopular” Obamacare individual mandate penalty and for enacting the so-called “Right to Try” law.

Democrats Introduce Medicare Drug Negotiation Bill

Presidential hopeful Sen. Sherrod Brown (D-OH) and Chairman of the Health Subcommittee of the House Ways and Means Committee Rep. Lloyd Doggett (D-TX) introduced legislation on Thursday that would allow Medicare to negotiate drug prices and strip patent exclusivity from pharmaceutical companies if those negotiations fail. The bill’s sponsors explained at a press conference Thursday that they were asking President Trump to return to his campaign promises to support Medicare drug price negotiation. Sen. Brown acknowledged that the bill faces slim odds of success in the GOP-controlled Senate, but said he hoped a strong vote in the House would “put the pressure on Senate Majority Leader Mitch McConnell.” Rep. Doggett clarified that the path forward for the bill remains unclear in the House as well, as there are multiple different bills on the topic.

Under the proposal from Sen. Brown and Rep. Doggett, the government could approve a generic competitor if a branded-drug manufacturer doesn't agree to a “reasonable” Part D price for a given medication. Generic-drug companies would have to pay royalties to the branded-drug manufacturer if their product is approved, and the price of the new generic could be modeled on prices paid in similar countries. The bill currently has around 100 Democratic co-sponsors.

House Democrats to Introduce Legislation to Combat Administration ACA Reform

The House Energy & Commerce Committee will hold a hearing this week to examine a suite of bills aimed at undoing changes the Administration has made to weaken the Affordable Care Act (ACA). On Wednesday, the Committee will discuss a package of bills, which would revoke the administration’s short-term plan rule, strike the revised state innovation waiver guidance, and restore ACA outreach funding. The hearing is part of an effort by the Democratic House majority to highlight what they call the Administration’s “sabotage” of the ACA and take actions to reverse it. The bills likely have no chance of passing through the GOP-controlled Senate, but they provide Democrats a chance to show their priorities and highlight Trump’s actions. The package of legislation includes:

  • The Protecting Americans with Preexisting Conditions Act of 2019 (H.R. 986) — Rescinds the Trump Administration’s revisions to state innovation waivers and introduced by Democratic Reps. Ann Kuster (NH), Joe Courtney (CT), and Don Beyer (VA).
  • H.R. 987 — Restores ACA market and outreach funding back to $100 million and disallow the money from being used to promote products that don’t comply with the ACA and introduced by Democratic Reps. Lisa Blunt Rochester (DE), Dan Kildee (MI), Lucy McBath (GA), and Kathy Castor (FL).
  • H.R. 1010 — Overturns the Trump administration’s expansion of short-term health plans and introduced by Democratic Reps. Lauren Underwood (IL), Kathy Castor (FL), Mark DeSaulnier (CA), and Gwen Moore (WI).

White House Council of Economic Advisors Lauds Trump ACA Changes

On Friday, the White House Council of Economic Advisors released a report arguing the changes the Administration had made to the ACA had been beneficial to the health care marketplace. The report examined the repeal of the individual mandate, association health plans for small businesses that can be sold across state lines, and sort-term, limited duration health plans. The Council reported that the law’s subsidies to assist low and middle income consumers pay premiums will keep the exchanges stable despite healthy individuals moving from the ACA Exchanges to participate in cheaper plans. The Administration also emphasized that the individual mandate was not necessary for the law to function, and that eliminating the penalty had not resulted in substantial decreases in enrollment.

FDA Releases Least Burdensome Provisions Final Guidance for Devices

Last Monday, the Food & Drug Administration (FDA) released final guidance entitled, "The Least Burdensome Provisions: Concept and Principles.” The guidance describes the FDA’s updated approach to ensuring the least burdensome principles to regulation of the medical device total product lifecycle. The guidance also aligns with the Administration’s goals to streamline regulatory processes and remove or reduce unnecessary burdens associated with regulatory activities. Last week’s final guidance was intended to update Least Burdensome Guidance from 2002, and supports implementation of the updated least burdensome provisions in the 21st Century Cures Act. The FDA will discuss the final guidance during a webinar on March 14 at which stakeholders will have an opportunity to ask FDA officials specific questions on the least burdensome principles.

The final guidance applies to all products that meet the statutory definition of a device, including device constituent parts of combination products. The Agency also stated that the policy applies to all activities, including premarket and postmarket actions, in the regulation of medical devices. The final guidance includes both premarket and postmarket examples to demonstrate approaches that the FDA and industry can take to ensure that least burdensome principles are implemented for all device-related applications and interactions with the FDA. The guidance also makes clear that this new approach does not change the applicable regulatory standards, such as the device approval or clearance standards, nor the applicable requirements, including premarket submission content requirements or the requirement for valid scientific evidence. According to the FDA, the updated principles are based on sound science, the intent of the law, the use of alternative approaches, and the efficient use of resources to effectively address regulatory issues.