Administration Issues Executive Order Tying Medicare Drug Costs to International Prices

Merle M. DeLancey Jr.

On Sunday, while everyone was watching the return of NFL football, the Administration was busy fulfilling a promise it made in July to lower drug prices paid by the United States and Medicare beneficiaries by tying pricing to certain foreign countries.

In July, the Administration issued three Executive Orders concerning drug pricing and access to critical therapies. At that time, the Administration also announced that, unless the pharmaceutical industry proposed a plan that would decrease prices paid by Medicare Part B by August 24, the Administration would move forward with its own plan. Apparently, no agreement with the industry was reached because on Sunday the Administration announced its own plan.

In what is being called the “Most Favored Nations” Executive Order, the Administration is re-starting its efforts to reduce the prices the United States pays for drugs under Medicare Parts B and D. The Order uses the “most-favored-nation price” as the benchmark for prices to be paid by the United States. Most-favored-nation price is defined as the lowest price, after adjusting for volume and differences in national gross domestic product, for a pharmaceutical product that the drug manufacturer sells in a comparable member country of the Organisation for Economic Co-operation and Development (“OECD”).

Perhaps most surprising is the increased scope of the Order. The Order goes beyond what was proposed in July by seeking to link not only Medicare Part B drug prices but also Medicare Part D prices to lower prices paid by other countries. With respect to both Medicare Parts, the Department of Health and Human Services’ (“HHS”) “payment model” is to test whether poor clinical outcomes improve as a result of patients paying lower prices—no more than the most-favored-nation prices—for certain high-cost pharmaceuticals and biologics.

While the Order makes for a snappy sound bite, any potential benefits of lower drug prices will not be seen anytime soon. First, HHS will need to complete its rulemaking, which could have its own challenges. For example, in November 2018, HHS published an Advance Notice of Proposed Rulemaking (“ANPR”) proposing to implement an international reference pricing payment model for use by Medicare and Medicaid. Ultimately, nothing became of the ANPR. Even then, implementation of the contemplated programs is precarious. Industry opposition to the Order has been palpable and any HHS plan will likely face legal challenges that could substantially delay implementation.

Our Clarion Call: Thoughts on Our 21-Day Racial Equity Habit Building Challenge

Dominique L. Casimir and Justin A. Chiarodo

A few weeks ago we wrote about our Government Contracts practice group’s decision to opt in to the 21-Day Racial Equity Habit Building Challenge (the “Challenge”) launched by the American Bar Association (“ABA”) Section of Public Contract Law. The 21-Day Challenge was a syllabus of 21 daily assignments—curated for the ABA by Dominique Casimir—focusing on the Black American experience, including Black history, identity and culture, the experience of anti-Black racism in America, and the intersection between systemic racism and the legal profession.

What We Did: We invited our clients to participate with us in a series of weekly discussion groups to share perspectives on the racial equity movement currently underway in this country, to reflect on how we got here, and to challenge ourselves to consider what we are doing—in our respective workplaces, and as individual lawyers—to work towards racial equality. This experience was unlike anything we have done with our clients before, and admittedly we were not sure how clients would respond when we invited them to engage with us in an ongoing series of small-group, candid discussions about a topic as sensitive as race. We were incredibly humbled that so many of our clients enthusiastically welcomed this opportunity. Continue reading “Our Clarion Call: Thoughts on Our 21-Day Racial Equity Habit Building Challenge”

GAO Signals More Demanding Approach to Corrective Action Dismissals

Luke W. Meier

About a third of U.S. Government Accountability Office (“GAO”) protests end because an agency decides to take voluntary corrective action. (This is evidenced by the ~30 percent difference between GAO’s “Sustain” rate and “Effectiveness” rate.) While it is considered a “win,” voluntary corrective action can be frustrating for protesters who may have no assurance their concerns will truly be addressed. Agencies often say little about what the corrective action will entail. When they do discuss specific steps to be taken, agencies often list various actions they may or may not take, depending on further assessment as the corrective action unfolds. Historically, GAO has largely brushed aside complaints about these uncertainties. When an agency announces its intent to take corrective action, the perfunctory next step has been a quick dismissal of the protest.

In a recent decision, however, GAO signaled a willingness to demand more from agencies seeking a dismissal based on corrective action. Continue reading “GAO Signals More Demanding Approach to Corrective Action Dismissals”

Seventh Circuit Weighs in on Government Dismissal Authority under the FCA

Sara N. Gerber

The Seventh Circuit’s recent decision in U.S. ex rel. CIMZNHCA, LLC v. UCB, Inc. widens the Circuit split on the standard of review applicable when the government seeks to dismiss a qui tam case under the False Claims Act (“FCA”). The FCA, 31 U.S.C. § 3730(c)(2)(A), provides that the government may dismiss a qui tam case without the relator’s consent if the relator is given notice and an opportunity to be heard. Although the Department of Justice (“DOJ”) has increasingly exercised its dismissal authority since issuance of the “Granston Memo” in January 2018—which encouraged DOJ attorneys to consider seeking dismissal if in the best interests of the government—as the Seventh Circuit noted, the FCA does not indicate “how, if at all,” courts are “to review the government’s decision to dismiss.” Circuit Courts have taken divergent views in answering that question.

Circuit Court Decisions

The D.C. Circuit, in Swift v. United States, 318 F.3d 250 (D.C. Cir. 2003), decided that the government has an “unfettered right” to dismiss based on the Executive branch’s “historical prerogative” to decline to prosecute a case. The Ninth Circuit, in U.S. ex rel. Sequoia Orange Co. v. Baird-Neece Packing Corp., 151 F.3d 1139 (9th Cir. 1998), and the Tenth Circuit in Ridenour v. KaiserHill Co., LLC, 397 F.3d 925 (10th Cir. 2005), imposed a rational-relation test: the government must establish a rational relation between dismissal and the accomplishment of a valid government purpose. If the government satisfies this test, the burden shifts to relator to show that dismissal is fraudulent, arbitrary and capricious, or illegal. So far, the Supreme Court has declined to step in, denying certiorari in April 2020 in United States ex rel. Schneider v. JP Morgan Chase Bank on the question of whether the government’s dismissal decisions constitute an “unreviewable exercise of prosecutorial authority.” Now, however, the Seventh Circuit has articulated a new standard, relying on Federal Rule of Civil Procedure 41(a) governing voluntary dismissals by plaintiffs. Continue reading “Seventh Circuit Weighs in on Government Dismissal Authority under the FCA”

KBR Subcontractor’s “Delay” Costs Rejected as Unreasonable by Federal Circuit, No Remand to Cure Defects

Stephanie M. Harden

In a September 1, 2020, ruling, the Federal Circuit addressed the reasonableness of subcontractor costs stemming from a government-caused delay under KBR’s LOGCAP contract in Iraq. This decision is important for contractors across all industries given the expected flood of COVID-19-related claims involving government-caused delays and/or idle time. The decision provides new guidance on what contractors must show to demonstrate the reasonableness of subcontractor costs.

The case involved a KBR subcontract to First Kuwaiti Co. of Kuwait (“First Kuwaiti”) to transport trailers into Iraq. The dissent (Judge Newman) explains the operational significance of expeditiously delivering these trailers: soldiers were sleeping in “abandoned schools, . . . tents, vehicles, the ground, or any other place soldiers could put a sleeping bag.” The Army tasked KBR with delivering more than 18,000 trailers to multiple locations in Iraq by Christmas 2003, a deadline which was important for both morale and tactical reasons. KBR, in turn, subcontracted to First Kuwaiti. Continue reading “KBR Subcontractor’s “Delay” Costs Rejected as Unreasonable by Federal Circuit, No Remand to Cure Defects”

Executive Order Regarding Domestic Production and Purchase of Essential Medicines: A Lot to Unpack and More Than Meets the Eye

Merle M. DeLancey Jr. and John M. Clerici 

On August 6, 2020, President Trump issued another Executive Order (“EO”) that will likely have dramatic and long-lasting effects on the pharmaceutical industry.[1] The impact of the EO may be far greater than currently anticipated. It is well-considered, well drafted, and structured in a way that is likely to survive if there is a change in Administration. The EO will have a greater and immediate impact on Medical Counter Measures (“MCMs”) for chemical, biological, radiological, and nuclear threats, and emerging infectious diseases than on Essential Medicines. The inclusion of Critical Inputs (i.e., active pharmaceutical ingredients (“API”)) and starting materials potentially makes the impact far reaching, especially when coupled with the significant funding from the federal government to support onshoring efforts as a result of the COVID-19 pandemic. Continue reading “Executive Order Regarding Domestic Production and Purchase of Essential Medicines: A Lot to Unpack and More Than Meets the Eye”

Government Reliance on Waiver Argument to Keep Price Adjustment Windfall Fails

Scott Arnold

Last week, the U.S. Court of Appeals for the Federal Circuit articulated limits to the government’s ability to rely on the waiver doctrine to enforce Federal Acquisition Regulation (“FAR”) provisions of questionable legality, and, in so doing, cast doubt on the government’s “heads we win, tails you lose” approach to measuring the cost impact of simultaneous changes to a contractor’s cost accounting practices.

In The Boeing Company v. United States, 2019-2148 (Aug. 10, 2020), the Federal Circuit rejected the government’s argument that Boeing’s claim—which was based on an apparent conflict between (1) a statutory provision limiting the costs the government may recover for cost accounting practice changes to the aggregate increased cost to the government, and (2) a FAR provision under which the government’s recovery considers only the changes that increase costs to the government, and disregards changes that decrease costs to the government—was waived because Boeing did not raise the issue prior to contract award. Continue reading “Government Reliance on Waiver Argument to Keep Price Adjustment Windfall Fails”

Preparing for the Rollout of the Cybersecurity Maturity Model Certification: It Is All about the Timing

Michael Joseph Montalbano

The Department of Defense (“DoD”) is expected to begin rolling out the Cybersecurity Maturity Model Certification (“CMMC”) program later this year. As a brief refresher, the CMMC is a certification system implemented by DoD to protect Controlled Unclassified Information (“CUI”) and other sensitive contract information. There are five CMMC levels of ascending sophistication. The most common CMMC levels are expected to be Level 1 and Level 3. Level 1 will require contractors to put into place basic safeguarding practices to protect federal contract information. Level 3 will require contractors to put into place more stringent safeguarding practices that are designed to protect CUI. Contractors receive their CMMC after they pass an assessment by a CMMC Third Party Assessment Organization (“C3PAO”) or an individual assessor.

Although DoD will not fully implement the CMMC program until 2026, more and more contracts will require offerors to hold a CMMC demonstrating that their organizations have implemented the necessary cybersecurity controls. A nightmare scenario for any defense contractor is to find itself unable to compete for a lucrative DoD contract due to insufficient time to obtain the required CMMC before proposal deadlines. Fortunately, the Accreditation Body (“AB”) that is responsible for rolling out the CMMC program has provided estimated timelines for contractors seeking a CMMC. Continue reading “Preparing for the Rollout of the Cybersecurity Maturity Model Certification: It Is All about the Timing”

Recent and Possible Executive Orders on Drug Pricing: What You Need to Know

Merle M. DeLancey Jr.

On July 24, 2020, President Trump signed three Executive Orders aimed at lowering prescription drug costs and increasing patients’ access to life-saving medications. A fourth Executive Order was discussed, which could reduce the prices Medicare Part B pays for drugs based upon international prices, unless the pharmaceutical industry implements measures in the next 30 days. Leaving politics and rhetoric aside, below are the key facts regarding the Executive Orders.

First Executive Order: Access to Affordable Life-Saving Medications

The Order: Click here to view the Order.

Effective Date:  July 24, 2020

Purpose: Requires Federally Qualified Health Centers (“FQHCs”) to pass on the discounted prices they pay for insulin and epinephrine to low income patients. FQHCs are federally funded, community-based health care providers serving low income patients and underserved areas. Under the Health and Human Services’ (“HHS”) 340B Drug Discount Program, drug manufacturers charge FQHCs statutorily discounted prices, sometimes as low as $0.01, for drugs including insulin and epinephrine. But FQHCs are not required to pass on the discounted prices to their patients. This Executive Order requires FQHCs to make insulin and epinephrine available to their patients at the price paid by the FQHC. The FQHC is permitted to charge a minimal administration fee. Continue reading “Recent and Possible Executive Orders on Drug Pricing: What You Need to Know”

Part B Interim Rule Bans Contractors from Using Covered Technology Starting August 13th: 5 Steps for Meeting the Compliance Deadline

Justin A. Chiarodo, Merle M. DeLancey, Jr., and Robyn N. Burrows

We previously discussed key elements of the newly released interim rule (“the interim rule” or “the rule”) implementing Part B of Section 889 (“Part B”), which prohibits the federal government from contracting with entities that use certain Chinese telecommunications equipment. This post provides a more detailed analysis of the scope and application of the rule, as well as five compliance recommendations given the impending August 13th deadline.

Rule Applies to All Contracts Effective August 13, 2020

Part B applies to all solicitations, options, and modifications on or after August 13th, including contracts for commercial items, commercially available off-the-shelf (COTS) items, and contracts at or below both the micro-purchase and simplified acquisition thresholds. Like it did with respect to Part A, GSA intends to issue a Mass Modification requiring contractors to certify compliance with Part B. GSA has also released Q&As and FAQs to assist contractors with Part B implementation. The interim rule acknowledges that Part B will have a broad impact across contractors in a range of industries, including healthcare, education, automotive, aviation, and aerospace. The rule, however, does not apply to federal grant recipients (which are subject to a separate rulemaking). Continue reading “Part B Interim Rule Bans Contractors from Using Covered Technology Starting August 13th: 5 Steps for Meeting the Compliance Deadline”