trump

March 19, 2019

Trump Administration Acts to Lower Medicare Prescription Drug Prices

The rising prices of existing and new brand prescription drugs could have serious consequences for tax payers and the 44 million seniors who rely on Medicare. In order to rein in those costs, it’s vital for the Administration to encourage the use of generic drugs and biosimilars.

While Congress has been grabbing the headlines by holding numerous hearings and introducing various legislative proposals aimed at lowering drug prices, the Trump Administration has introduced some consumer-friendly changes to Medicare that should change the way drugs are priced for seniors and encourage the use of generics and biosimilars. First, the Centers for Medicare & Medicaid Services (“CMS”) proposes to change how insurance plans and PBMs conduct drug utilization management and structure drug formularies. Second, the U.S. Department of Health and Human Services (“HHS”) proposes to eliminate the rebates that pharmacy benefit managers (“PBMs”) receive from drug manufacturers and to encourage that any rebates go directly to seniors at the point of sale.

These significant reforms are necessary as the stakes are high. Since 2006, Medicare Part D spending has more than doubled to roughly $100 billion per year in 2017, and it is expected to climb as a growing and aging population of baby boomers becomes Medicare eligible. Today, despite making up a modest proportion of Part D prescriptions, brand drugs account for some 84% of total Part D spending. Generics, meanwhile, which make up most of the Part D prescriptions, account for only 16% of the total spending and saved the Part D program approximately $82 billion in 2017.

October 10, 2018

Trump Signs Two Bills into Law Banning PBM Gag Clauses

by Doyle, Barlow & Mazard PLLC

On a day, that President Trump’s Department of Justice approved CVS’ acquisition of Aetna, allowing the vertical integration of a pharmacy benefit manager with a health insurer, he signed two bills into law intended to lower patients’ prescription costs: the Know Your Lowest Prices Act and the Patient Right (S. 2553) to Know Drug Prices Act (S. 2554). The bills prohibit health insurers and pharmacy benefit managers (“PBMs”) from including so-called “gag clauses” in contracts with pharmacies. The clauses ban pharmacists from notifying patients when they could pay less for medicines without using their health insurance than they would for their copayment.

The Laws Should Reduce Patient Out-of-Pocket Spending by Eliminating Gag Clauses and Increase Drug Pricing Transparency

It is important to eliminate pharmacy gag clauses that prevent pharmacists from informing consumers of lower priced alternatives. In a competitive market, we would expect providers would have the ability to guide consumers to the best products at the lowest cost. The fact that PBMs had a practice of preventing pharmacies from disclosing this information means competition was not working as it should.

September 17, 2018

Patient Access to Affordable Medicines: How a Renegotiated NAFTA Could Keep Drug Prices High

by Doyle, Barlow & Mazard PLLC

On Friday, September 14^th, a Congressional briefing was held regarding the renegotiation of NAFTA and how certain changes under discussion could end up undermining the President’s Blueprint to lower drug prices in the United States by extending pharma monopolies. One of the provisions under discussion would increase brand-name drug exclusivity. Imposing additional brand-name drug exclusivity only keeps already high brand drug prices out of reach for patients for longer.

The panelists included representatives from Association for Accessible Medicines (Jeff Francer), Mylan (Marcie McClintic Coates), Patients for Affordable Drugs (David Mitchell), and AARP (Leigh Purvis). Watch the briefing here: https://www.youtube.com/watch?v=9K3RQHB-oTE

They explained how one of most promising areas of drug research is the creation of generic biologic medicines, or biosimilars. These drugs have great potential and often offer the best treatments for serious diseases such as cancer, multiple sclerosis, rheumatoid arthritis, and others. Yet, today, there are only four biosimilars on the market in the United States.

February 22, 2018

Is the Selective Enforcement Defense Applicable To Antitrust Cases?

by Doyle, Barlow & Mazard PLLC

On February 21, 2018, Judge Leon ruled against AT&T Inc.’s (“AT&T”) ability to discover evidence that would support its selective enforcement defense.

Background

On November 21, 2017, the U.S. Department of Justice’s (“DOJ”) Antitrust Division filed a complaint in federal court block AT&T’s acquisition of Time Warner Inc. (“Time Warner”).

February 14, 2018

Politics Unlikely to Play a Role in Defense of Time Warner Deal

by Doyle, Barlow & Mazard PLLC

On February 14, 2018, it was reported that AT&T Inc. (“AT&T”) identified as a potential witness for trial, Makan Delrahim, the head of the U.S. Department of Justice’s (“DOJ”) Antitrust Division. AT&T’s request for the antitrust chief to testify is highly unusual, but would appear necessary given that AT&T is claiming as a defense that the DOJ’s action to block the deal is an “improper selective enforcement of the antitrust laws.”

It is common practice in the early stages of litigation to be overly inclusive when identifying witnesses for trial, and just because Delrahim is named does not necessarily mean that he will testify. However, when alleging selective enforcement as a defense, AT&T will necessarily need to put on proof of the improper discrimination behind the DOJ’s decision to block its deal with Time Warner, and presumably no one would be in a better position to testify as to the DOJ’s decision than the actual decision maker: Delrahim.

In addition to its witness list, AT&T has also requested internal communications between Delrahim’s office and Attorney General Jeff Sessions, including emails, phone calls and other communications between the White House and officials at the DOJ.

January 10, 2018

Business as Usual: Trump Administration Targets Consummated Mergers

by Doyle, Barlow & Mazard PLLC

Historically, the FTC and DOJ have sought to unwind consummated mergers that are deemed to be anticompetitive. During Trump’s first year in office, the FTC and DOJ have demonstrated their willingness to unwind anticompetitive mergers that somehow sneaked by the regulators.

FTC Seeks to Unwind Merger of Prosthetic Knee Manufacturers

On December 20, 2017, the FTC filed an administrative complaint to unwind the merger of Otto Bock HealthCare North America, Inc., (“Otto Bock”) and FIH Group Holdings, LLC (“Freedom”), two manufacturers of prosthetic knees equipped with microprocessors that adapt the joint to surface conditions and walking rhythm. In September 2017, the parties simultaneously signed a merger agreement and consummated the merger without the FTC having an opportunity to review the deal. Apparently, the merger was not HSR reportable. According to the FTC, the merger eliminated direct and substantial competition between head to head competitors that engaged in intense price and innovation competition. While the litigation is ongoing, the parties agreed to a Hold Separate and Asset Maintenance Agreement, which prevents them from continuing the integration of the two businesses. The FTC did not allege any violation of the HSR ACT.

January 18, 2017

Will President Trump Interfere With Antitrust Reviews?

by Doyle, Barlow & Mazard PLLC

About a week before taking office, President-elect Trump had two high level meetings with CEOs of companies that are involved in significant acquisitions currently under antitrust review by the Department of Justice’s Antitrust Division. The meetings raise questions about the integrity and independence of the DOJ’s merger reviews going forward under a Trump administration.

AT&T/Time Warner

On January 12, 2017, AT&T Inc. (“AT&T”) Chief Executive Officer Randall Stephenson said that in his meeting with President-elect Donald Trump they touched on job creation, investment and competition, but he noted that AT&T’s merger with Time Warner Inc. (“Time Warner”) did not come up. We find that hard to believe given President-elect Trump’s open reservations about the transaction and his ongoing battle with CNN.