Health Care Contracting

As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States.  The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than 2,000 to 3,000 new cases each day.

Due to the lack of approved therapeutics, vaccines, and diagnostics for this threat, developing new products and testing products already approved for other uses is a high priority for the U.S. interagency response effort—the Medical Countermeasure (MCM) Task Force.  The Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), is leading this Task Force in partnership with U.S. Department of Defense, Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health.

BARDA is currently looking at the effectiveness of existing countermeasures for similar viruses, as well as potential new responsive technologies, including vaccines, diagnostics, therapeutics, and medical supplies.  BARDA is serving as the sole point of entry for product and technology submissions to ensure there is an expedited process for receipt and review of proposed solutions for 2019-nCoV.  In this capacity, BARDA has released two opportunities to submit potential solutions for the 2019-nCoV response discussed below: (1) the EZ-BAA for 2019-nCoV diagnostics and (2) market research packages for any and all potential products and supplies.  Covington encourages those with technology that could be potentially useful to respond.Continue Reading U.S. Government Seeks Industry Solutions in Novel Coronavirus Response

On November 6, 2019, the Department of Labor’s Office of Federal Contract Compliance Programs (“OFCCP”) issued a Notice of Proposed Rulemaking (“NPRM”) aimed at resolving what OFCCP describes as a “decade of confusion.”[1] At issue is a long-standing question concerning the scope of OFCCP’s enforcement authority over health care providers participating in TRICARE, a federal health care program covering millions of military personnel, veterans, and their families. In particular, the NPRM requests comments on proposed regulations that would amend OFCCP’s definition of “subcontractor” and thereby remove TRICARE providers–and potentially other categories of providers–from OFCCP’s regulatory authority entirely. The deadline for filing comments is December 6, 2019.
Continue Reading OFCCP Proposes Rule Removing TRICARE Health Care Providers from Its Regulatory Authority

Last week, the White House Office of Science and Technology Policy (“OSTP”) issued a request for information (“RFI”) to learn how the Government can more effectively “support scientific discovery, the development of technological advances, and increase the impact of a vibrant bioeconomy on the Nation’s vitality and our citizens’ lives.” 84 Fed. Reg. 47561 (Sep. 10, 2019). The Bioeconomy is the “infrastructure, innovation, products, technology, and data derived from biologically-related processes and science that drive economic growth, promote health, and increase public benefit.” Id. To establish guiding principles to promote and protect the U.S. Bioeconomy, OSTP is seeking input from interested parties, including “those with capital investments, performing innovative research, or developing enabling platforms and applications in the field of biological sciences, to include healthcare, medicine, pharmaceuticals, biotechnology, manufacturing, energy production, and agriculture.” Id. Of particular interest to government contractors, OSTP is seeking information regarding opportunities for public-private partnerships, infrastructure investments, and best practices for data sharing and data protection. Id. at 47562. Responses are due on or before 11:59 pm on October 22, 2019. We have included the specific topics on which OSTP seeks input below.
Continue Reading White House Seeks Input from Biotech Stakeholders on Bioeconomy

After more than eight years in the making, the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (the “Rule”) seems to be a rudderless ship on a shoreless sea. On Monday, the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking delaying the implementation date of the final Rule from July 1, 2018 to July 1, 2019. The final Rule was published eighteen months ago (January 5, 2017) and the implementation date has since been delayed on four different occasions. HRSA has cited a variety of reasons for each delay—compliance with the Regulatory Freeze issued by the incoming Trump Administration; providing stakeholders additional time to prepare for compliance with the Rule; yet more time for compliance preparations; and additional time for HRSA to “fully consider the substantial questions of fact, law, and policy raised by the [R]ule.”
Continue Reading The 340B Ceiling Price and CMP Rule . . . Changes on the Horizon?

Last week, the Fourth Circuit Court of Appeals affirmed a lower court decision to dismiss a Telephone Consumer Protection Act (“TCPA”) lawsuit against General Dynamics Information Technology, Inc. (“GDIT”), on the basis that GDIT was immune from suit as a government contractor under what is known as the “Yearsley doctrine.”  Craig Cunningham v. GDIT, No. 17-1592 (Apr. 24, 2018). The decision follows a long line of Fourth Circuit decisions in which contractors have been granted protection from liability when they perform work that supports important governmental functions. 
Continue Reading Fourth Circuit Embraces Expansive View of Derivative Sovereign Immunity for Government Contractors

Recent news reports have raised a substantial question about who has authority to run the Department of Veterans Affairs (“VA”) in the wake of Dr. David Shulkin’s departure from the agency.  According to the White House, Dr. Shulkin resigned.  Meanwhile, Dr. Shulkin himself has publicly insisted that he did not resign and was instead fired.

This inconsistency sets up a potential dispute over whether, under the Federal Vacancies Reform Act of 1998 (“Vacancies Act”), President Trump had the authority to appoint Robert Wilkie, the Undersecretary of Defense for Personnel & Readiness, to serve as Acting Secretary of the VA.

As a result, contractors doing business with the VA have found themselves confronted with a series of knotty questions about the impact this uncertainty may have on the VA’s procurement priorities and actions.Continue Reading If Shulkin Didn’t Resign, Who Runs the VA Until a New Secretary Is Confirmed? A Vacancies Act Puzzle

On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs. HB 4005 also imposes new reporting requirements on health insurers and establishes a temporary task force charged with developing “a strategy to create transparency for drug prices across the entire supply chain of pharmaceutical products.”[1]
Continue Reading Oregon HB 4005: New Reporting Requirements for Drug Manufacturers, Health Insurers

A generic pharmaceutical distributor, Acetris Health, LLC, has challenged the Final Determination of U.S. Customs and Border Protection (“Customs”) that Acetris’ generic prescription drug, Rosuvastatin Calcium Tablets (“Rosuvastatin”), is a product of India, the place where the active pharmaceutical ingredient (“API”) is produced.  If successful, the challenge in the U.S. Court of International Trade (“CIT”) could have a meaningful impact on decisions about where to manufacture API for the very broad range of drug products sold to the U.S. Government.
Continue Reading The Long-Standing TAA “Substantial Transformation” Standard for Drug Products is Challenged at the Court of International Trade

Over the last few weeks, much attention has been paid to California’s recently enacted SB 17, legislation that requires pharmaceutical manufacturers to report certain price increases of prescription drugs and, in some cases, provide a justification for such increases. The legislation also requires health insurers and health plans to report additional rate information to state agencies. California’s push to impose disclosure of prescription drug pricing information is part of a growing trend of proposed and enacted legislation across the country purportedly aimed at increased price transparency and control.
Continue Reading California Law Aims to Scrutinize Drug Pricing

This week, the Department of State (“State”), Verité, and other global NGOs, unveiled a sample human trafficking compliance plan and online resource to help contractors comply with the FAR’s anti-human trafficking rule (the “Rule”).  As we have previously summarized, the Rule requires contractors to implement a compliance plan for contracts exceeding $500,000 that are for non-COTS goods or services acquired outside the United States.  Because the final Rule included few specifics on compliance plan requirements, contractors have sought guidance regarding their responsibilities to implement a plan and perform supply chain due diligence.  The recently-released sample compliance plan and other web-based tools at ResponsibleSourcingTool.org appear to provide some guidance.
Continue Reading Sample Human Trafficking Compliance Plan Finally Released